Sr. Associate, Clinical Research (Non-MD)
Core
Author and support clinical evaluation documentation (CEPs, CERs, PMCF Plans/Reports, SLRs) for medical device products, ensuring alignment with EU MDR 2017/745 and regulatory guidance.
Role type
Senior Associate, Clinical Research (Non-MD)
Builds
Clinical evaluation deliverables and lifecycle documentation for medical devices
Domain
Medical Devices / Regulatory Affairs
Required skills
EU MDR 2017/745 compliance, clinical evaluation, systematic literature review, evidence appraisal, risk management interfaces, benefit-risk concepts, document control, data interpretation
Preferred skills
Ophthalmic medical devices experience
Technologies
Microsoft Office, document management systems, literature databases, reference management tools, clinical evaluation platforms
Responsibilities
Author and update clinical evaluation documentation; Perform structured literature reviews and evidence synthesis; Integrate post-market and risk management data; Support cross-functional reviews; Manage deliverables and timelines; Contribute to process improvements
Seniority
Senior, hands-on IC