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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 primary function of a Medical Writer-Clinical Evaluation Report Medical Writer (CER MW), is to combine understanding of scientific and research methodology, medical device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, AIMDD, MDCG Guidance documents, and EU MDR 2017/745.

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform the following:

• The CER MW is a subject matter expert for guidelines and regulations regarding the clinical evaluation process and its consequent documents (e.g., CEP, CER, PMS Plan, PMCF Plan, PMCF Report, and SSCP).
• Prepare regulatory documents and responses to regulatory authorities, specifically working on Clinical Evaluation Reports (CERs) for EU and Clinical Study Reports (CSRs) for US
• Perform routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical devices
• Perform critical review and data analysis from clinical investigations and literature for incorporation into the CER
• The CER MW will interact cross-functionally with various personnel to identify and obtain relevant documentation and data on safety, performance, adverse events and risk/benefit profile of a device or devices.
• Ensure documents are produced in accordance with procedures, internal and external guidelines, and electronic templates
• Manages all aspects of outsourced or internal CER/CSR production and ensures project delivery with other functions

Education/Experience Required:

The ideal candidate will offer:

• Previous experience writing CERs and related documents in accordance with MEDDEV 2.7/1 rev 3 and 4, EU MDR 2017/1 Rev.4, MDCG Guidance on clinical evaluations, post-market surveillance (PMS, PMCF guidance, plans, reports) for medical devices (minimum BS/MS + 5 years experience)
• Training and degree in science, engineering, or medical fields. Scientific/research background (i.e., understands research design, methodology, and statistics)
• Broad experience managing the medical writing responsibilities associated with multiple studies at various stages
• Effective written, verbal and presentation skills in the area of technical/clinical applications
• Strong command of medical terminology
• Demonstrated ability to identify and adapt to shifting priorities and competing demands
• Work independently with minimal supervision, multi-task, and work effectively under pressure
• Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
• Read, write and speak fluent English; excellent verbal and written communication skills
• Certification is a plus (e.g, RAC, PMP)
• Ability to travel as needed

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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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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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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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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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