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Quality Systems Consultant
Job Title: Quality Systems Consultant
Classification: Full Time
Location: Remote
Travel (%): 50%

Company Summary:
MEDIcept is an international medical device, IVD, combination product and biotechnology compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost- effective Regulatory, Quality, and Clinical services.

Please see www.medicept.com for more information.

Position Summary:
The Quality Systems Consultant is a hands-on role supporting the Quality Management Systems department. Must be a self-starter and a multi-tasker, as this position will work on multiple exciting client projects in tandem.

Essential Duties and Responsibilities:
• Successfully develop and manage Quality Management Systems to meet FDA QSR, ISO 13485, EU MDR, MDSAP, and other applicable regulatory requirements.
• Conduct / lead / assist clients with internal, supplier, ISO 13485, CE Mark, MDSAP audits and FDA inspections.
• Perform recidivist certification and due diligence audits.
• Compliance strategy development, including enforcement action responses and/or corrective action plans (483s, warning letters, etc.), recall strategies.
• Supplier Quality Management activities, including supplier audits and corrective action process (SCAR).
• Deliver customized client training and education programs.
• Corrective action strategy and development.
• Preparation for FDA inspections and registrar or Notified Body assessments.
• Identify client processes that may require improvement, correction, or additional contracted resources.
• Successfully plan, manage, execute, and close turnkey projects within budget, and on time.
• Develop strong relationship with clients, providing timely and accurate communications.
• Deliver customized client training and education programs on Quality Management Systems and other industry topics.
• Potentially serve as client adjunct quality staffing (Interim Quality Professional)

Skills and Qualifications:
• Bachelor’s degree in Engineering, Regulatory and Compliance Management, Quality Engineering, or in a closely related / equivalent field.
• Minimum five (5) years of experience monitoring and maintaining quality management systems to ensure compliance with government regulations within the medical device, life sciences industry.
• Auditing and in-depth knowledge and experience working with 21 CFR Parts 820, 803, 806 and ISO 13485, ISO 9001, EU MDR and related International Requirements.
• Lead Auditor or Auditor certification a plus.
• Proven hands-on experience with document management, training, CAPA, electronic system development/validation, management review, risk management, and quality improvement initiatives.
• Excellent communication (oral, written and verbal) and time management skills required.
• Must be detail-oriented, thorough, and organized.
• Excellent interpersonal skills with a customer service focus.
• Ability to manage multiple projects simultaneously.
• Must be self-motivated, able to work both independently and with a team.
• Software (ISO 62304) and Usability (ISO 62366) experience a plus.
• Project Management experience a plus.

Please note the following:
• Must be legally authorized to work in the U.S.
• We are not currently sponsoring work visas.
• Relocation is not available for this position as it is a remote role
• We are an Equal Employment Opportunity employer. Drug free workplace.
• We are following all state guidelines relative to safety precautions.

Regulatory Consultant

Seniority Level: Mid-level
Industry: Medical Device / IVD / Biotech
Employment Type: Employee
Location: Remote (US based)
Travel: Yes (~5%)

MEDIcept is an international medical device, IVD, combination product and biotechnology compliance consulting firm. For 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost- effective Regulatory, Quality, and Clinical services.
Please see www.medicept.com for more information.

Position Summary: Hands-on role supporting the Director of Regulatory Services with the growth of the Regulatory side of the business. A self-starter and a multi-tasker, this position will work on multiple exciting projects in tandem, mostly with limited supervision. While strong regulatory expertise is a must, time management and communication are equally as important. 

Duties and Responsibilities

  • Work with clients to determine classification and regulatory pathway for US, EU, and other international markets.
  • Manage multiple, parallel projects to successful completion.
  • Prepare and submit 510(k)s, Non-filling justifications, Technical Files, Investigational Device Exemptions, and Clinical Evaluation Reports.
  • Liaise with the FDA on pre-submissions, 510(k)s, and deNovo applications.
  • Liaise with client’s Notified Body regarding Technical File submissions.
  • Evaluate and troubleshoot client prepared regulatory submissions.
  • Labeling / advertising / promotional material assessment.

Skills and Qualifications

  • Minimum 5 years of related regulatory experience, including:
  • Regulatory position with small or start-up company.
  • Writing and submitting at least one 510(k) in past two years.
  • Writing at least one EU MDR or IVDR Technical Files in past two years.
  • Writing at least one new product introduction regulatory strategy.
  • Experience with submitting Pre-Submission meeting requests into the FDA and participating in those meetings.
  • Experience with assessing device changes for regulatory notification device labeling including UDI
    Knowledge and documented training to EU MDR, IVDR and FDA regulations required.
  • Experience with international product approval/registrations, such as UK, China, Brazil, Japan, India, and Australia a plus.
  • Experience with PMAs desired.
  • RAC certification a plus.
  • Unique Device Identifier experience a plus.
  • Experience with CLIA license submissions a plus.
  • Previous consulting and clientele relationship experience a plus.
  • Must possess excellent verbal and written communications skills, as well as presentation and project management skills.
  • Experience with Microsoft Word, Excel, PowerPoint, and Outlook required
  • Must employ excellent time management and organizational skills required to be a remote consultant

Please note the following:

  • Must be legally authorized to work in the U.S.
  • We are not currently sponsoring work visas.
  • Relocation is not available for this position as it is a remote role
  • We are an Equal Employment Opportunity employer. Drug free workplace.
  • We are following all state guidelines relative to safety precautions.

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Quality Systems Senior Consultant (ex-FDA)

Investigator experience a must.Classification: Full Time
Location: Remote (must be US based)
Travel: Yes, ~50%

Position Summary:

The Quality Systems Senior Consultant is a hands-on role supporting the Quality Management Systems department. Must be a self-starter and a multi-tasker, as this position will work on multiple exciting client projects in tandem.

Essential Duties and Responsibilities: (will be variable depending on the nature of the client projects to be undertaken)

  • Successfully develop and manage Quality Management Systems to meet FDA QSR, ISO 13485, EU MDR, MDSAP, and other applicable regulatory requirements.
  • Conduct / lead / assist clients with internal, supplier, ISO 13485, CE Mark, MDSAP audits and FDA inspections.
  • Perform recidivist certification and due diligence audits.
  • Compliance strategy development, including enforcement action responses and/or corrective action plans (483s, warning letters, etc.), recall strategies.
  • Supplier Quality Management activities, including supplier audits and corrective action process.
  • Deliver customized client training and education programs.
  • Corrective action strategy and development.
  • Preparation for FDA inspections and registrar or Notified Body assessments.
  • Identify client processes that may require improvement, correction, or additional contracted resources.
  • Successfully plan, manage, execute, and close turnkey projects within budget, and on time.
  • Develop strong relationship with clients, providing timely and accurate communications.
  • Deliver customized client training and education programs on Quality Management Systems and other industry topics.
  • Potentially serves client adjunct quality staffing (Interim Quality Professional)

Skills Requirements:

  • Bachelor’s degree in Engineering, Regulatory and Compliance Management, Quality Engineering, or in a closely related / equivalent field.
  • Minimum ten (10) years of experience monitoring and maintaining quality management systems to ensure compliance with government regulations within the medical device, pharmaceutical, biotechnology, etc.
  • Former FDA Investigator experience a must.
  • Auditor and in-depth knowledge and experience working with 21 CFR Parts 4, 820, 210/211, 803, 806 and ISO 13485, 14971, EU MDR, EU IVDR and related International Requirements.
  • Lead Auditor certification a plus.
  • Excellent communication (oral, written and verbal) and time management skills required.
  • Must be detail-oriented, thorough, and organized.
  • Excellent interpersonal skills with a customer service focus.
  • Ability to manage multiple projects simultaneously.
  • Must be self-motivated, able to work both independently and with a team.
  • Software (ISO 62304) and Usability (ISO 62366) experience a plus.
  • Project Management experience a plus.

Please note the following:

  • Applicants for this position must be legally authorized to work in the U.S.
  • We are not currently sponsoring work visas.
  • Relocation is not available for this position as it is a remote role.
  • We are an Equal Employment Opportunity employer. Drug free workplace.
  • We are following all state guidelines relative to safety precautions.

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Quality Systems Consultant – Europe

Classification: Full Time
Location: Europe, must be fluent in German and English
Travel: Yes, candidate must have the desire and ability to travel

Position Summary

The Quality Systems Consultant is a hands-on role supporting the Quality Management Systems department. Must be a self-starter and a multi-tasker, as this position will work on multiple exciting client projects in tandem.

Essential Duties and Responsibilities: (will be variable depending on the nature of the client projects to be undertaken)

  • Successfully develop and manage Quality Management Systems to meet FDA QSR, ISO 13485, EU MDR, MDSAP, and other applicable regulatory requirements.
  • Conduct / lead / assist clients with internal, supplier, ISO 13485, CE Mark, MDSAP audits, and FDA inspections.
  • Perform recidivist certification and due diligence audits.
  • Compliance strategy development, including enforcement action responses and/or corrective action plans (483s, warning letters, etc.), recall strategies.
  • Supplier Quality Management activities, including supplier audits and corrective action process.
  • Deliver customized client training and education programs.
  • Corrective action strategy and development.
  • Preparation for FDA inspections and registrar or Notified Body assessments.
  • Identify client processes that may require improvement, correction, or additional contracted resources.
  • Successfully plan, manage, execute, and close turnkey projects within budget and on time.
  • Develop strong relationships with clients, providing timely and accurate communications.
  • Deliver customized client training and education programs on Quality Management Systems and other industry topics.
  • Potentially serve as client adjunct quality staffing (Interim Quality Professional).

Skills Requirements:

  • Bachelor's degree in Engineering, Regulatory and Compliance Management, Quality Engineering, or in a closely related / equivalent field.
  • Minimum five (5) years of experience monitoring and maintaining quality management systems to ensure compliance with government regulations within the medical device manufacturing industry. Experience to include:
    • Quality auditing experience to ensure compliance with ISO and FDA regulations.
    • Performing corrective and preventive action to address compliance issues.
    • Participating in FDA inspections.
  • Fluent (reading and speaking) in English and German.
  • Working knowledge and documented training in ISO 13485, FDA Quality System Regulation, and EU MDR.
  • Proven hands-on experience with document management, training, CAPA, electronic system development/validation, management review, risk management, and quality improvement initiatives.
  • Excellent communication and time management skills are required.
  • Lead Auditor certification is a plus.
  • Software experience is a plus, including knowledge of ISO 62304.
  • Usability experience is a plus, including knowledge of ISO 62366.
  • Electromechanical experience is a plus, including knowledge of ISO 60601.

Please note the following:

  • Relocation is not available for this position as it is a remote role.
  • MEDIcept guarantees equal opportunities throughout the application process and compliance with local legislation in each country where MEDIcept Inc. operates. MEDIcept excludes any discriminatory factors, including but not limited to gender and age, ethnicity, religion or belief, sexual orientation, or disability.

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Quality Systems Consultant (Combination Product SME)

Classification: Full Time
Location: Remote (must be US based)
Travel: Yes, ~50%

Position Summary:

The Quality Systems Consultant and Combination Product SME is a hands-on role supporting the Quality Management Systems department. This position includes supporting customer Quality requests and providing services related to current US and international regulations/guidelines/policies applicable to Combination Products. Must be a self-starter and a multi-tasker, as this position will work on multiple exciting client projects in tandem.

Essential Duties and Responsibilities: (will be variable depending on the nature of the client projects to be undertaken)

  • Successfully develop and manage Quality Management Systems to meet FDA QSR 820, 210/211, Part 4, ISO 13485, EU MDR, MDSAP, and other applicable regulatory requirements.
  • Conduct / lead / assist clients with internal, supplier, ISO 13485, CE Mark, MDSAP audits, and FDA inspections.
  • Perform recidivist certification and due diligence audits.
  • Compliance strategy development, including enforcement action responses and/or corrective action plans (483s, warning letters, etc.), recall strategies.
  • Supplier Quality Management activities, including supplier audits and corrective action process (SCAR).
  • Deliver customized client training and education programs.
  • Corrective action strategy and development.
  • Preparation for FDA inspections and registrar or Notified Body assessments.
  • Identify client processes that may require improvement, correction, or additional contracted resources.
  • Successfully plan, manage, execute, and close turnkey projects within budget and on time.
  • Develop strong relationships with clients, providing timely and accurate communications.
  • Deliver customized client training and education programs on Quality Management Systems and other industry topics.
  • Potentially serve as client adjunct quality staffing (Interim Quality Professional).

Skills and Qualifications:

  • Bachelor’s degree in Chemical, Biomedical, Mechanical, Material Science Engineering, or related field.
  • Minimum ten (10) years of experience monitoring and maintaining quality management systems to ensure compliance with government regulations within the medical device and life sciences industry, including drug product development experience.
  • Auditing and in-depth knowledge and experience working with 21 CFR Parts 4, 820, 210/211, 803, 806, ISO 13485, EU MDR, EU IVDR, and related International Requirements.
  • Experience with Post Market Safety Reporting, current Good Manufacturing Practice (cGMP) requirements for combination products; single-entity and co-packaged combination products.
  • Lead Auditor or Auditor certification a plus.
  • Proven hands-on experience with document management, training, CAPA, electronic system development/validation, management review, risk management, and quality improvement initiatives.
  • Excellent communication (oral, written, and verbal) and time management skills required.
  • Must be detail-oriented, thorough, and organized.
  • Excellent interpersonal skills with a customer service focus.
  • Ability to manage multiple projects simultaneously.
  • Must be self-motivated, able to work both independently and with a team.
  • Project Management experience a plus.

Please note the following:

  • Applicants for this position must be legally authorized to work in the U.S.
  • We are not currently sponsoring work visas.
  • Relocation is not available for this position as it is a remote role.
  • We are an Equal Employment Opportunity employer. Drug free workplace.
  • We are following all state guidelines relative to safety precautions.

APPLY NOW

Associate Medical Device Consultant/Leadership Immersion Program

Leadership Immersion Program

Consultant – “Associate Medical Device Consultant”

Seniority Level:  Associate

Industry:  US and EU Medical Device/IVD/Biotech

Employment Type: Permanent

Location: Remote (US based)

Travel:  Yes

Application Deadline: 1/31/2023

Company Summary: MEDIcept is an international medical device and IVD compliance consulting firm. For 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost- effective Regulatory, Quality, and Clinical services.

MEDIcept is also a Clinical Service Organization supporting clinical trials & studies for device, IVD, pharma and combination products through the entire product lifecycle. Our clinical team has experienced project managers, CRAs/monitors, data manager, statistical programmers, and statisticians as well as safety officers to support all aspects of clinical study management pre- and post-approval.

Please see www.medicept.com for more information.

Position Summary:  Note: This role is remote

The Associate Consultant is a 3-year immersion program position in which the Consultant is trained on three fundamental areas of the medical device industry to include Clinical Affairs, Regulatory Affairs and Quality Management System Services. There will be hands-on rotational exposure in these three areas within the first 12-18 months of the program. This rotation will allow the Consultant to explore a variety of different aspects of the medical device industry. After this initial development period, the Consultant will be coached and mentored to develop Subject Matter Expertise in one of the three regulated disciplines noted. With continued mentoring throughout the program, the Consultant will expand both their experience and knowledge in the field. The first three years of MEDIcept employment within the Leadership Immersion Program will entail:

Enrolling and successfully completing the MEDIcept professional development training program, consisting of three months of internal training.

  • Completing three rotations (~3 months each) of understudy on a MEDIcept client project, overseen by the SME in the areas of Clinical, Regulatory, and Quality Services.
  • Developing continuing education and training plans to work towards obtaining and maintaining professional certification(s) in areas of interest and work experience.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following:

  • Provide input and solutions to internal practices, programs to advance MEDIcept as a leader in the in the industry.
  • Adhere to company timekeeping and expense policies.
  • Deliver customized client training and education programs.
  • Lead adjunct staffing project with MEDIcept temporary consults, ensuring completion and effective project goals.
  • Assist with development and expansion of MEDIcept services, maintaining general knowledge in current regulatory, quality, clinical affairs, and business practices.
  • Identify client-regulated processes that may require improvement, correction, or additional contracted resources.
  • Successfully plan, manage, execute, and close turnkey projects within budget, and on time.
  • Draft proposals and time costing where business opportunities are identified.
  • Determine project measures of success, in quality, delivery time, and costs.
  • Develop strong relationships with clients, providing timely and accurate communications.
  • Resolve concerns, issues, and conflicts to ensure Client expectations are met, and project deviations are agreed upon and understood.
  • Assist with time study, project costs and reporting on project deliverables.
  • Agree to a minimum of three (3) years contract.

Education/Experience Required: The ideal candidate will offer:

  • Bachelor's degree or equivalent experience in Engineering, Regulatory and Compliance Management, Quality Engineering, or a closely related/equivalent scientific field.
  • Excellent communication and time management skills required to interact with all management and associates levels.
  • Excellent organizational skills with the ability to manage across multiple projects.
  • Proficient in MS Office applications.
  • Ability to travel as needed

Experience Preferred:

  • Working knowledge of ISO 13485, FDA regulations for medical devices, and EU MDR/IVDR requirements.
  • Project Management skills desired.
  • Relatable experience or internships in a medical device, biotech, IVD, or related industry such as:
  1. Experience monitoring and maintaining quality management systems, or
  2. Creating regulatory filings/submissions, or
  3. Participating in medical device clinical studies, or
  4. Participating in Post-market surveillance, complaint management, or
  5. Project manager for device design and development of Design History File.

Soft Skills: 

  • Comfortable in new situations and environments.
  • Adept at managing changing priorities, direction, and dissent.
  • Ability and willingness to prepare and present technical topics to an audience.
  • Understanding of other perspectives/personality/views.

Learn More

Software Quality Engineer
Seniority Level: Mid-level
Industry: Medical Device / IVD / Biotech
Employment Type: Permanent
Location: Remote (must be US based)
Travel: Yes, candidate must have the desire and ability to travel

Company Summary:
MEDIcept is an international medical device, IVD, combination product and biotechnology compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost- effective Regulatory, Quality, and Clinical services.

Please see www.medicept.com for more information.

Position Summary:
Technical, hands-on role to support our rapidly expanding Quality team. A self-starter and a multi-tasker, this individual will work on multiple exciting projects in tandem, with limited supervision. While software quality engineering experience in the medical device industry are must-haves, time management and communication are equally important.

Relocation to the Boston area is not required; successful candidate can work remotely from their home office and at client site as needed.

Essential Duties and Responsibilities:
• Work with clients to develop IEC 62304, ISO 13485, 21 CFR 820, 60601 compliant documentation (all product/software classifications)
• Design History File audits for compliance to IEC 62304, 60601, 21 CFR 820, ISO 13485.
• Serve as client Software Quality Engineering function including assistance with software development documents (including cybersecurity), risk management files, and 60601 deliverables.
• Must be able to assist clients with risk-based decisions using critical thinking
• Leading and mentoring Agile software teams:
o Development Lifecycle Planning
o Requirement Development
o Hazard Analysis
o Cybersecurity Threat Modeling
o Anomaly Analysis
o Verification documentation methods
o Automated testing
• Cybersecurity implementation development, including post-market Vulnerability Monitoring.
• Identify client processes that may require improvement, correction, or additional contracted resources.
• Successfully plan and manage multiple, parallel projects to successful completion, on time and within budget.
• Develop strong relationships with clients, providing timely and accurate communications.

Skills and Qualifications:
• Bachelor's degree in Engineering, Computer Science, or in a closely related / equivalent field.
• Minimum five years of experience in quality engineering including software quality environment within the Medical Device industry.
• Proven hands-on experience with implementation of IEC 62304, ISO 13485, and ISO 14971.
• Knowledge of AI/ML, Bluetooth, IoT, and mobile devices.
• Working knowledge of Part 11, IEC 60601, Human Factors, EU MDR, and medical device cybersecurity (e.g., UL 2900, AAMI TIR57 and TIR97, ISO 27001, IEC 62443, NIST SP 800-53, NIST 800-30, SOC Type 2).
• Hands-on ability to work autonomously to problem-solve.
• Excellent communication, time management, and analytical skills required.
• Experience with small / startup company desired.
• Electromechanical experience a plus, including knowledge of IEC 60601.
• Experience with regulatory submission content creation a plus.
• Must possess excellent verbal, time management, and written communications skills.
• Previous consulting and clientele relationship experience a plus.

Please note the following:
• Must be legally authorized to work in the U.S.
• We are not currently sponsoring work visas.
• Relocation is not available for this position as it is a remote role
• We are an Equal Employment Opportunity employer. Drug free workplace.
• We are following all state guidelines relative to safety precautions.

Risk Management Quality Engineer
Seniority Level: Mid-level
Industry: Medical Device / IVD / Biotech
Employment Type: Permanent
Location: Remote (must be US based)
Travel: Yes, candidate must have the desire and ability to travel

Company Summary:
MEDIcept is an international medical device, IVD, combination product and biotechnology compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost- effective Regulatory, Quality, and Clinical services.

Please see www.medicept.com for more information.

Position Summary:
Technical, hands-on role to support our rapidly expanding Quality team. A self-starter and a multi-tasker, this individual will work on multiple exciting projects in tandem, with limited supervision. While Risk Management and Process Validation experience in the medical device industry are must-haves, time management and communication are equally important.

Relocation to the Boston area is not required; successful candidate may work remotely from their home office and at client site as needed.

Essential Duties and Responsibilities
• Provide risk management support and expertise to clients during their product development and post market cycle, ensuring that risks are identified, control measures are defined, verified and effective, in accordance with the latest revision of ISO 14971
• Create and remediate product-related files and reports, including complete Risk Management Files, Clinical Risk Management Reports, Review of Post Production Information, and General Safety and Performance Requirements to support compliance efforts and enhance product safety and performance.
• Review and compile post-market surveillance data as related to risk management.
• Provide leadership and expertise to client product development teams to ensure risk management principles are applied throughout the design process.
• Review and develop process and design FMEA’s.
• Assist with client root-cause analysis for design, process, and risk related CAPA’s.
• Provide product risk expertise input to Health Hazard Evaluations.
• Provide leadership and expertise to client process development teams to ensure risk management principles are applied to drive process validations and throughout the production phase.
• Manage multiple, parallel projects to successful completion.
• Act as embedded Quality Engineering team member for clients, including risk management lead, design and process change impact assessments, process validation support, application of statistical techniques, and Design Reviews.
• Perform Risk Management gap assessments or audits against applicable standards including ISO 14971, IEC 60601, IEC 62304, 21 CFR 820, ISO 13485
• Develop and present training sessions on Risk Management principles
• Must be able to assist clients with risk-based decisions using critical thinking
• Identify client processes that may require improvement, correction, or additional contracted resources.
• Successfully plan and manage multiple, parallel projects to successful completion, on time and within budget.
• Develop strong relationships with clients, providing timely and accurate communications.

Skills and Qualifications
• Bachelor's degree in Electrical, Mechanical, or Biomedical Engineering or in a closely related / equivalent.
• Minimum five years of experience in quality engineering including risk management and process validation disciplines within the Medical Device industry.
• Proven hands-on experience including implementing compliance to ISO 14971:2019
• Hardware and Software product experience, preferred
• Working knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, FDA Quality System Regulation, and EU MDR.
• Able to apply statistical techniques to risk analysis and process validation. CQE and/or six sigma black belt a plus.
• Hands-on ability to work autonomously and learn on the fly to problem-solve.
• Excellent communication, time management, and analytical skills required.
• Experience with small / startup company desired.
• Must possess excellent verbal, time management, and written communications skills.
• Previous consulting and clientele relationship experience a plus.

Please note the following:
• Must be legally authorized to work in the U.S.
• We are not currently sponsoring work visas.
• Relocation is not available for this position as it is a remote role
• We are an Equal Employment Opportunity employer. Drug free workplace.
• We are following all state guidelines relative to safety precautions.

Quality Systems Generalist
Job Title: Quality Systems Generalist
Classification: Full Time
Location: Remote
Travel (%): 50%

Company Summary:
MEDIcept is an international medical device, IVD, combination product and biotechnology compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost- effective Regulatory, Quality, and Clinical services.

Please see www.medicept.com for more information.

Position Summary: (this is just a high-level overview of the role as a whole) Example:
The Quality Systems Generalist is a hands-on role supporting the Quality Management Systems department. Must be a self-starter and a multi-tasker, as this position will work on multiple exciting client projects in tandem.

Essential Duties and Responsibilities:
• Assist with development and management of Quality Management Systems to meet FDA QSR, ISO 13485, EU MDR, MDSAP, and other applicable regulatory requirements.
• Conduct / lead / assist clients with internal, supplier, ISO 13485, CE Mark, MDSAP audits and FDA inspections.
• Manage the day-to-day administration of documents to support releases and changes in compliance with client’s policies and procedures (e.g., document and engineering change control).
• Supports review, update, filing and distribution of controlled documents, including standard operating procedures and technical documents.
• Create trend reports for quality systems (e.g., CAPA, Change Control, Training).
• Perform recidivist certification and due diligence audits.
• Supplier Quality Management activities, including supplier audits and corrective action process (SCAR).
• Assist with preparation for FDA inspections and registrar or Notified Body assessments.
• Identify client processes that may require improvement, correction, or additional contracted resources.
• Successfully plan, manage, execute, and close turnkey projects within budget, and on time.
• Develop strong relationship with clients, providing timely and accurate communications.
• Deliver customized client training and education programs on Quality Management Systems and other industry topics.
• Potentially serve as client adjunct quality staffing (Interim Quality Professional)
Skills and Qualifications:
• Bachelor’s degree in Engineering, Regulatory and Compliance Management, Quality Engineering, or in a closely related / equivalent field.
• Minimum three (3) years of experience monitoring and maintaining quality management systems to ensure compliance with government regulations within the medical device, life sciences industry, PLM (e.g., Arena) or eQMS (e.g., QT9) experience a plus.
• Auditing and in-depth knowledge and experience working with 21 CFR Parts 820, 803, 806 and ISO 13485, ISO 9001, and related International Requirements preferred, EU MDR a plus.
• Lead Auditor or Auditor certification a plus.
• Strong technical computer skills with proficiency using various computer programs and web-based applications, including Microsoft Word, Excel, PowerPoint, One Drive, SharePoint, Dropbox, Box, Egnyte, etc.
• Proven hands-on experience with document management, training, CAPA, electronic system development/validation, management review, risk management, and quality improvement initiatives.
• Excellent communication (oral, written and verbal) and time management skills required.
• Must be detail-oriented, thorough, and organized.
• Excellent interpersonal skills with a customer service focus.
• Ability to manage multiple projects simultaneously.
• Must be self-motivated, able to work both independently and with a team.
• Project Management experience a plus.
Please note the following:
• Must be legally authorized to work in the U.S.
• We are not currently sponsoring work visas.
• Relocation is not available for this position as it is a remote role
• We are an Equal Employment Opportunity employer. Drug free workplace.
• We are following all state guidelines relative to safety precautions.

Talent Acquisition Specialist

Job Title:            Talent Acquisition Specialist       

Reports to:        Talent Acquisition Manager                     

Classification:    Full Time

Location:            Remote

Travel (%):         <5%

Company Summary:

MEDIcept is an international medical device, IVD, combination product and biotechnology compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost- effective Regulatory, Quality, and Clinical services.

Please see www.medicept.com for more information.

Position Summary:

The Talent Acquisition Specialist will perform end-to-end recruitment in line with business requirements, liaising with hiring managers and the Talent Acquisition Manager to fill vacant positions in alignment with business objectives. Utilizing a suite of tools, you will advertise, proactively source and prequalify candidates that match company or client requirements.

Essential Duties and Responsibilities:

  • Proactively develops candidate pipelines and talent pools, developing relationships through networking and direct candidate sourcing.
  • Screening and selecting candidates for a wide range of positions from entry level to senior specialist
  • Scheduling of candidate assessments and interviews, including travel arrangements, coordinating interviewer schedules, and other tasks associated
  • Collaborates with the hiring manager and/or other human resource staff during the offer process, identifying salary ranges, incentives, start dates, and other pertinent details
  • Draft job adverts for a variety of media and advertise the available vacancies and career opportunities both internally and externally.
  • Ensures compliance with relevant employment laws and regulations, and company policies.
  • Maintains Applicant Tracking System and provides data analytics and reports as required.

Skills and Qualifications:

  • Recruitment experience in a Talent Acquisition or Agency capacity, within the Life Science sector.
  • Proven track record in both active & passive recruitment.
  • Ability to work with team members and hiring managers in a remote setting.
  • Strong attention to detail, organization, and follow-up skills.
  • Excellent written and verbal communication skills.
  • Strong computer skills including Microsoft Office applications, and Applicant Tracking System knowledge is a plus.

Please note the following:

  • Must be legally authorized to work in the U.S.
  • We are not currently sponsoring work visas.
  • Relocation is not available for this position as it is a remote role
  • We are an Equal Employment Opportunity employer. Drug free workplace.
  • We are following all state guidelines relative to safety precautions.
Accounting & HR Administrator

Job Title:            Accounting & HR Administrator

Reports to:        HR Director

Classification:    Full Time

Location:            Ashland Office – Not Remote

Company Summary:

MEDIcept is an international medical device, IVD, combination product and biotechnology compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost- effective Regulatory, Quality, and Clinical services.

Please see www.medicept.com for more information.

Position Summary:

This position will be responsible for accounts payable, assisting with payroll, and administrative duties supporting the Human Resources function. This individual will review and pay all vendor bills. They will review payroll reports, identify inaccuracies, and coordinate payments with payroll company. Several clients pre-pay pass-through costs; this individual will track those specific vendor bills, reconcile them, track the pre-payment amount and notify department heads when pre-payments are exhausted. They will track sick and vacation time and provide a monthly report to HR and the payroll company.

Essential Duties and Responsibilities:

  • Maintain current accounts, verify, and reconcile invoices and statements.
  • Review employee expenses for compliance.
  • Ensure that all vendor invoices are calculated, coded, entered, and applied properly on a timely basis.
  • Manage accounts payable inbox and other forms of invoice and query submissions.
  • Track and manage client pass-through pre-payments.
  • Reconcile to the bank account.
  • Perform check run on a weekly basis, prepare, and mail checks/submit payment electronically.
  • Analyze all accounts payable queries in a timely manner to resolve contract, invoice, or documentation discrepancies.
  • Assemble and send out annual 1099 and W2 tax forms.
  • Maintain HR/employee files, running periodic audits and ensure the accuracy of the employee data in the HR/Payroll system.
  • Address issues and questions regarding payroll from employees and superiors.
  • Process payroll changes and updates including, but not limited to: hours worked, additional earnings, tax deductions, holidays, employee benefits, new hire details, salary updates and termination data.
  • Assists in the implementation of company-wide human resources programs.
  • Collaborate cross functionally to create solutions to support fellow team members and management.

Required Skills and Qualifications:

  • High School Diploma is required.
  • Minimum 2-years previous experience in accounts payable
  • Proficient in Quickbooks
  • Must be proficient in Microsoft Excel
  • Competency with Microsoft Office programs
  • Must be detail-oriented, thorough, and organized
  • Strong analytical and problem-solving skills
  • Excellent oral, written and verbal communication skills
  • Excellent interpersonal skills with a customer service focus
  • Ability to manage multiple projects simultaneously
  • Must be self-motivated, able to work both independently and with a team

 Preferred Skills & Qualifications:

  • Accounting degree or equivalent experience preferred.
  • Experience working with ADP payroll software preferred.

Please note the following:

  • Must be legally authorized to work in the U.S.
  • We are not currently sponsoring work visas.
  • You must be able to commute to the office in Ashland, Massachusetts on a daily basis.
  • This is not a remote role.
  • Relocation is not available for this position.
  • We are an Equal Employment Opportunity employer. Drug free workplace.

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