Sr. Associate, Clinical Research (Non-MD)

Key Responsibilities:

1. Author, co-author, and support updates to CEPs, CERs, PMCF Plans and Reports, SLR protocols/reports, and related clinical evaluation documentation for assigned medical device products.

2. Apply clinical evaluation requirements, internal procedures, templates, and evidence appraisal expectations to produce clear, traceable, scientifically sound, and audit-ready deliverables.

3. Ensure clinical evaluation deliverables are developed in alignment with EU MDR 2017/745 , applicable MDCG guidance , MEDDEV guidance where relevant, internal procedures, and other applicable regulatory, clinical evaluation, and post-market guidance.

4. Perform structured literature review activities, including search strategy development and execution, screening, data extraction, appraisal support, evidence synthesis, and documentation of rationale and traceability.

5. Integrate clinical, post-market, risk management, PMS, PMCF, labeling, and state-of-the-art evidence into clinical evaluation deliverables with appropriate guidance and review based on deliverable complexity.

6. Support cross-functional review with Regulatory Affairs, Medical Safety, Design Excellence, and Quality teams to resolve comments and maintain alignment across lifecycle documentation.

7. Manage assigned deliverables to agreed timelines, proactively communicating risks, dependencies, open questions, and escalation needs.

8. Contribute to clinical evaluation process improvements, template refinements, reusable content, and knowledge-sharing practices that improve consistency and efficiency.

9. Demonstrate familiarity with and compliant use of approved clinical evaluation systems, Microsoft Office tools, literature databases, reference management tools, document management platforms, templates, and other authorized clinical evaluation or literature review tools, including appropriate documentation, version control, traceability, data integrity, and adherence to applicable procedures and tool-use requirements.

10. Develop increasing independence, technical judgment, and ability to manage clinical evaluation deliverables of increasing complexity.

Key Requirements/Minimum Qualifications:

· Quality, accuracy, traceability, and defensibility of assigned clinical evaluation deliverables.

· Timely completion of assigned CERs, CEPs, PMCF Plans/Reports, SLRs, and lifecycle updates against agreed project timelines.

· Effective incorporation and resolution of cross-functional review comments with clear rationale and documentation.

· Consistent use of approved templates, procedures, literature review methods, and evidence appraisal expectations.

· Demonstrated growth in independence, technical judgment, and ability to manage increasingly complex clinical evaluation deliverables.

· Bachelor’s Degree / Master’s Degree / PhD / Pharm D

· Minimum of 3 years of relevant experience in EU MDR 2017/745 medical device regulations, clinical evaluation, clinical evidence, regulatory medical writing, systematic literature review, clinical research, or a related scientific/regulatory function.

· Experience in ophthalmic medical devices is preferred.

· Foundational to strong working knowledge of EU MDR clinical evaluation expectations, MEDDEV 2.7/1 Rev. 4, applicable MDCG guidance, PMCF, PMS, risk management interfaces, and benefit-risk concepts

· Ability to author, update, and support technical review of CERs, CEPs, PMCF · · · Plans/Reports, SLRs, and related lifecycle documentation

· Understanding of research methodology, clinical study design, literature review methods, evidence appraisal, and data interpretation

· Ability to follow approved templates, procedures, and document control expectations in a regulated medical device environment

· Strong attention to detail, analytical thinking, documentation discipline, and ability to maintain audit-ready rationale and traceability

· Ability to collaborate effectively with Regulatory Affairs, Medical Safety, Quality, Design, and clinical stakeholders

· Ability to manage assigned deliverables, communicate status and risks, and escalate open issues appropriately.

· Proficiency with Microsoft Office tools, document management systems, literature databases, reference management tools, and approved clinical evaluation or literature review platforms, with compliant use consistent with applicable procedures and data integrity expectations

· Experience within a global environment, including flexibility to work off-peak hours as needed to accommodate multiple time zones

Work hours: 10 AM to 06 PM IST

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