Position Details
Medical Writer Cer Clinical Evaluation Apply
Position Summary
We are seeking an experienced Medical Writer with strong expertise in Medical Device Regulation (MDR) compliant documentation, including Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), and Summary of Safety and Clinical Performance (SSCP). The ideal candidate will have experience in medical device or pharmaceutical environments and the ability to collaborate with cross-functional teams to deliver high-quality regulatory documentation.
Key Responsibilities
- Prepare and maintain MDR-compliant regulatory documents including CERs, CEPs, and SSCPs.
- Conduct literature reviews and clinical data analysis to support clinical evaluation documentation.
- Collaborate with clinical, regulatory, quality, and R&D teams to gather and interpret clinical data.
- Support clinical evaluation strategies for medical devices in compliance with regulatory requirements.
- Ensure documentation aligns with global regulatory standards and internal quality procedures.
- Manage multiple writing projects and deliver high-quality documents within timelines.
- Review and update existing documentation based on new clinical data, regulatory updates, and product changes.
Required Qualifications
- Bachelor's degree in Biomedical Sciences, Life Sciences, Medicine, or a related health discipline.
- 6 8 years of medical writing experience in the medical device or pharmaceutical industry, OR 8+ years of technical writing experience in a regulated environment.
- Proven experience writing MDR-compliant CERs, CEPs, and SSCPs.
- Strong Microsoft Office proficiency (Word, Excel, PowerPoint).
- Excellent written and verbal communication skills.
- Strong analytical and critical thinking skills with attention to detail.
- Ability to work effectively in cross-functional, collaborative teams.
Preferred Qualifications
- Experience in vascular or other medical device therapeutic areas.
- Experience supporting clinical study management or clinical research activities.
- Background in biomedical sciences, medicine, or other health-related disciplines.
- Prior experience preparing Clinical Evaluation Reports (CERs) for regulatory submissions.
