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Job Title: Clinical Project Manager

Classification: Permanent

Travel: Yes, up to 25%

Position Summary: Clinical Project Manager will be responsible for managing multiple projects simultaneously to support the completion of tasks and deliverables. Additionally, the position is responsible to communicate cross-functionally, and with Sponsors, vendors, suppliers, contractors, sites, and upper management on project related activities.

Our ideal candidate is someone who thrives in a fast-paced and dynamic environment, and takes initiative to seek out information, knowledge, and development, proactively. They should be a resourceful problem solver who is savvy with technology and finds effective and efficient solutions to complex client problems. The Clinical Project Manager is a true self-starter who deals well with uncertainty and ambiguity. Lastly, they are a proven team player who puts the success of the team first.

Essential Duties and Responsibilities: We are looking for a detail-oriented clinical professional to join our growing Clinical team as a Clinical Project Manager to work closely with Clinical Operations and Clinical Affairs to ensure compliance with regulatory authorities.

This role will provide you the opportunity to coordinate and support key product development activities while gaining knowledge of product development. These responsibilities include some of the following:

• Details daily coordination, understanding and oversight of scheduled activities, considering responsibilities needed to carry out contracted work and compiling status updates on all projects deliverables
• Prepares professional communications and assist in the design of new tasks and projects.
• Coordinates and/or conducts investigations to resolve data discrepancies and reconcile data as appropriate
• Assist clients, collaborators, and senior management in the implementation of new projects and expanded work scopes
• Understands project scope including the creation of or supporting the Project Manager in compiling and maintaining project timelines, and attending internal and client meetings
• Preparation and submission of all required documents to internal and external stakeholders
• Proactively anticipates and facilitates future business opportunities with existing and prospective clients
• Independently conducts regularly scheduled touch bases with clients
• Maintains contract/project financial data
• Stay apprised of all repository and laboratory operations (fresh/frozen sample handling, data entry, shipping, etc.) if needed
• Reviews and approves all documentation associated with project(s) as required
• Following up on action items to ensure completion
• Project resource planning and reporting of project forecasts and actuals
• Track detailed technical deliverables and provide outlook on future deliverables
• Communicate with key business partners (internal and external) to ensure accurate and up to date information is maintained for program delivery
• Provide regular (weekly/biweekly) project communications with Clin Ops regarding key clinically meaningful data

Requirements:

• At least 3 years of clinical project management experience is strongly preferred
• Proven record of management of multiple trials and study teams
• Demonstrate working knowledge of internal SOP's, FDA/lCH guidelines to GCP's and regulatory compliance.
• Must have good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
• Must have knowledge of and direct experience with Microsoft Office: Word, Excel, PowerPoint, OneNote, Outlook, and Adobe Acrobat
• Experience with controlled clinical terminology and clinical trial systems such as TMF/eTMF, CTMS, EDC, IVRS/IWRS, ePRO is highly preferred
• Excellent interpersonal, active listening, and influencing skills
• Strong attention to detail, critical thinking skills to identify and solve problems
• Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company and external partners
• Strong organizational skills in order to maintain a high level of productivity and setting priorities in order to complete assignments in a timely manner
• Exhibit high initiative, strong drive, and follow-through
• Effective project management and organizational skills
• Good computer skills
• Ability to effectively conduct oral presentations
• Demonstrated experience in identification and resolution of technical problems in a professional environment
• Ability to maintain a high degree of confidentiality with clinical teams
• Ability to attain, maintain and apply a working knowledge of applicable procedural documents
• Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others
• Excellent interpersonal, active listening, and influencing skills
• Excellent written and effective verbal communication skills. Read, write and speak fluent English; excellent verbal and written communication skills
• Team player. Able to establish and maintain professional and productive working relationships with team members
• Prior regulatory experience is a plus
• Ability to travel as needed

Education/Experience Required: The ideal candidate will offer:

• Bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field 3+ years of clinical research experience in industry settings, as a CPM with additional responsibilities in line with Sr. CPM or Program Manager
• Previous industry experience as a CPM that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & experience.

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.

Job Title: Controller

Classification: Full time

Location: Office in Ashland, MA

Travel (%): <5%

Position Summary:  The Controller is responsible for having a finger on the pulse of the financial health of the organization. This position requires preparing timely financial reports, analyzing data, and measuring business metrics. A solid working knowledge of Excel and QuickBooks is a requirement of the position to work with accrual accounting and spreadsheet analysis. This position is best suited for an analytical person who understands how to interpret data relative P&L and other financial statements.

Essential Duties and Responsibilities:

Lead all accounting and financial operations to include cash flow management; budget management; financial KPI management; oversee payroll; accounts receivable and payable; short/long term financial health; financial risk and tax strategy; financial trending and projection. Specifically:

• Lead FP&A (Financial Planning and Analysis) with Executive Committee to develop long-range financial projections
• Develop, measure, and communicate key financial performance metrics of our business; evaluate our financial performance and productivity against industry benchmarks; innovate and work with Executive Committee to develop strategies to close any gaps and improve performance
• Manage the communication of key client project financial information to Executive Committee
• Establish and maintain detailed departmental budgets and KPIs working closely with Department leaders
• Be responsible for tax strategy, projections, and filings with our tax accountants; assist our tax accountants on any related matters
• Own and manage internal self-audits and external audits with outside auditors
• Maintain compliance with all federal and state laws

• Use Salesforce, QuickBooks, Timesheets, and Excel to identify pipeline and revenue streams.

Skills and Qualifications:

• A BS or MS in Finance and/or Accounting or MBA
• A minimum of 5 years of working experience leading the financial and operational functions
• 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 experience with Salesforce.
• Preferred experience with QuickBooks.

Please note the following:

• This is a hybrid position with a minimum of 3 days in office, Ashland, MA
• Must be legally authorized to work in the U.S.
• We are not currently sponsoring work visas.
• Relocation is not available for this position.
• We are an Equal Employment Opportunity employer. Drug free workplace.
• We are following all state guidelines relative to safety precautions.

Job Title: Office Manager

Classification: Full Time

Location: Ashland, MA

Position Summary:

Our company is seeking a reliable, organized, and detail-oriented Office Manager to oversee the daily operations of our office. The Office Manager will be responsible for ensuring that office operations and procedures are organized, managing administrative tasks, managing with timesheets and accounts receivable, assisting with HR functions, and supporting the President with daily responsibilities.

Essential Duties and Responsibilities:

• Process and track invoices and expenses in QuickBooks, ensuring accuracy and timely payments.
• Maintain timesheet data for employees and contractors.
• Assists in the collection of payments from clients.
• Assist with the onboarding of new staff members, including coordinating the necessary equipment and programs needed for their jobs.
• Provide administrative support for executive-level staff including scheduling appointments and meetings, travel coordination, and calendar management.
• Maintain employee files and ensure compliance with HR policies and procedures.
• Manage day-to-day office operations, including answering phones, greeting visitors, and handling incoming and outgoing mail and packages.
• Assist in planning and execution of company events.
• Manage office inventory, office supplies, equipment, and furniture, as needed.
• Ensure the office environment is clean, safe, and welcoming for staff and visitors.

Skills and Qualifications:

• High school diploma or equivalent required.
• Associate or Bachelor’s degree in Business Administration or related field preferred.
• At least 2-3 years of experience in an administrative or office management role.
• Proficient in Microsoft Office, Google Suite, and QuickBooks.
• Familiarity with basic accounting and HR principles.
• Excellent organizational and time management skills.
• Strong communication and interpersonal skills.
• Ability to multitask and prioritize effectively in a fast-paced environment.
• High level of attention to detail and accuracy and ability to multi-task in a fast-paced environment.

Please note the following:

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

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.

Investigator experience a must.

Classification: Full Time
Location: Remote (must be US based)
Travel: ~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.

APPLY NOW

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.

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.

Job Title: Payroll & Accounting Administrator

Classification: Full Time

Date Posted: 10/20/2023

Travel: N/A

Position Summary:

The Payroll & Accounting Administrator will perform a wide range of accounting and administrative functions with a focus on Payroll.

Essential Duties and Responsibilities:

• Enter, review, and process employment actions in ADP Work Force Now including entering new hire information, transfers, promotions, and terminations.
• Research and resolve any payroll discrepancies in a timely manner.
• Review, respond, and process wage garnishment orders in accordance with state and federal laws.
• Prepare and review all payroll reports for accuracy, prior to final payroll processing.
• Set-up Tax Jurisdiction information to add new states as employees are hired nationally.
• Maintain knowledge of payroll systems and accounting, as well as Federal/State wage & hour laws.
• Respond promptly and courteously to all payroll inquiries from employees.
• Assist the finance department with questions on the payroll account bank statement.
• Partner with peers to ensure managing tasks effectively which includes cross training for coverage purposes.
• Ensure all required monthly and quarterly tax reports are run by ADP.
• Run reports and reconcile invoices for benefits.
• Process employment verifications and enter ledger reports in QuickBooks.
• Monthly reconciliation of Timesheet, QuickBooks, and ADP time off balances.
• Assist with answering incoming phone calls and direct the calls to the appropriate consultant. While doing so, promote a customer service mindset to ensure strong support for our clients, consultants, and employees.
• Provide routine office tasks, such as filing and generating reports.
• Assist with the maintenance of documentation for all transactions in support of organizational financial requirements including audits, legal notices, or other regulatory compliance.
• Maintain employee and customer records in QuickBooks.
• Assist with incoming and outgoing mail and packages.

Experience Requirements:

• Requires 2+ years of experience in ADP Work Force Now
• Proficient in Microsoft programs including Word, Excel, Teams Required
• Proficient in QuickBooks Accounting preferred
• Strong numerical aptitude and attention to detail
• Excellent communication skills, both verbal and written
• Good time management and organizational skills
• Excellent Customer Service
• Ability to operate with urgency and meet deadlines.
• Ability to work with minimal supervision with latitude for independent judgment while meeting the goals and objectives of the organization.
• Ability to manage multiple projects simultaneously.
• Ability to lift up to 25 pounds.
• Must be self-motivated, able to work both independently and with a team.

Experience Preference:

• Proficient in QuickBooks Accounting preferred

Please Note the Following:

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

Job Title: 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: 1/31/2024

Company Summary: MEDIcept is an international medical device and IVD compliance consulting firm. For three decades, our unique consulting practice has assisted thousands of companies of all sizes with cost- effective Clinical Affairs, Regulatory Affairs, Quality Management System, and Quality/Software Engineering Services.

MEDIcept is also a Clinical Service Organization supporting clinical trials & studies for medical device, IVD, 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: The Associate Consultant is a 3-year immersion program position in which the Consultant is trained on five fundamental areas of the medical device industry to include Clinical Affairs, Regulatory Affairs, Quality Management System, Quality/Software Engineering and Business Development. There will be hands-on rotational exposure in these areas within the initial 12-18 months of the program. These rotations 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 disciplines noted above. 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:

• Foundational internal training.
• Completing rotations (~2-3 months each) of understudy on a MEDIcept client project, overseen by the SME in the areas of Clinical Affairs, Regulatory Affairs, Quality Management System,Quality/Software Engineering and Business Development 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 medical device consulting 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 associate levels.
• Excellent organizational skills with the ability to manage 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