Medical Writer - Clinical Evaluation Reports (CER) and Post-Market Surveillance (PMS)

Description

JOB SUMMARY:

The Senior Medical/Technical Writer will help develop, maintain, and update Clinical Evaluation (CEPs, CERs) and post-market surveillance (PMSP/PMSR, PMCF, PSUR, SSCP) documentation for medical devices in accordance with (EU) MDR 2017/745. They will be responsible for regularly conducting systematic literature reviews on biomedical databases and searches of vigilance/adverse event databases for PMS. This role is critical to ensuring the company’s medical devices meet global regulatory requirements and that all documentation is accurate and compliant.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

Clinical Evaluation Reports (CER): Contribute to planning, authoring, updating, and maintaining clinical evaluation plans/reports in accordance with EU MDR 2017/745, MEDDEV 2.7/1 Rev 4, MDCGs, other guidance documents/standards, and internal SOPs. This includes conducting systematic literature reviews following PICO and PRISMA to gather relevant clinical data on the subject device and the state of the art.  The clinical data is to be summarized, tabulated, appraised, and analyzed to establish acceptance criteria and evaluate subject device conformity with requirements.  Conduct reviews to maintain data integrity.  Gather and present data in the CER from various internal/external sources such as risk management documentation, pre-clinical reports, complaints, PMS, and PMCF. 

Post-Market Surveillance (PMS): Contribute to the preparation of PMS plans/reports, PMCF, PSURs, and SSCPs in compliance with EU MDR 2017/745, MDCGs, other guidance documents/standards, and internal SOPs. Develop PMCF plans/reports to proactively gather data from surveys, literature reviews, PMCF studies, etc. Work with a cross functional team to gather, present, and analyze PMS data. Conduct thorough searches of vigilance databases such as MAUDE for the subject device and state of the art. Tabulate and analyze vigilance data. Conduct proactive literature reviews for the subject device and state of the art. Regularly update CERs with PMS/PMCF data. Prepare PMSRS/PSURs and SSCPs. 

Technical Reviews: Conduct technical reviews of CER and PMS documentation to ensure data integrity, accuracy, and compliance with procedures.

Regulatory Documentation: Ensure all CER and PMS documentation is accurate, up-to-date, and compliant with international regulatory standards. Ensure that CER and PMS documentation is properly linked to other QMS documentation such as risk management files, IFUs, etc.

Regulatory Updates: Stay informed about changes in international regulatory standards and guidelines related to CER and PMS and communicate these changes to relevant stakeholders within the company.

Other key responsibilities include but are not limited to Managing daily activities to ensure timelines are met. Participating in workshops and other initiatives to help define and continuously improve process efficiency. Participating in continuous education activities to improve understanding of associated regulatory requirements and industry trends/practices. Supporting and, at times, acting as a subject matter authority during audits and inspections pertaining to processes and reports.

KNOWLEDGE, SKILLS AND ABILITIES:

• In-depth knowledge of international regulatory standards related to CER and PMS (e.g., MEDDEV 2.7/1 Rev 4, EU MDR, MDCG documents).
• Must be able to adapt to change in the workplace and demonstrate flexibility with new ideas. 
• Ability to communicate in writing and orally with supervisors and co-workers.
• Good understanding of operational environment and analytical skills.
• Must be self-motivated and a good team player.
• Proficiency in using Microsoft Office Applications, especially MS Word, MS Excel, MS PP, MS Outlook.
• Excellent written and verbal communication skills.
• Strong attention to detail and organizational skills.
• Demonstrated knowledge and experience in quality, regulatory compliance, adverse event reporting, medical device risk management processes, and common statistical  

Requirements

EDUCATION AND EXPERIENCE:

• Minimum of a Bachelors’ Degree is required, preferably in a Science related field (Medical Engineering or Medicine preferred); Advanced Degree is highly desired.
• Minimum of 2 years of related Clinical and/or Technical Writing experience in a highly regulated industry.
• Experience within the medical device industry and knowledge of CER/PMS regulatory requirements, evidence generation, and CER/PMS document creation.
• Regulatory/Notified Body audit experience strongly preferred.

PHYSICAL REQUIREMENTS:

• This is a remote position.
• Must be able to operate a computer and other office productivity machinery, such as a computer printer, computer keyboard, calculator, etc.
• Ability to listen and speak with employees, auditors, managers, colleagues.
• View and type on computer screens for long periods of time
• Occasional travel might be required.

This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.