nasar

Assistant Manager – Regulatory Affairs (EU MDR Clinical Evaluation)

Independently authored standard sections and updates of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Summary of Safety and Clinical Performance (SSCP) documents for complex medical device portfolios under Medical Device Regulation (MDR).. Executed systematic literature search strategies, systematically cataloged database extractions, and documented objective appraisal outcomes utilizing PubMed and Embase frameworks.. Analyzed National Joint Registry (NJR) data alongside clinical trial outputs to isolate, interpret, and report long-term safety and performance profiles.. Drafted specialized Post-Market Surveillance (PMS) templates, Periodic Safety Update Reports (PSUR), and Post-Market Clinical Follow-up (PMCF) summaries to optimize lifecycle clinical evidence tracking.. Developed comprehensive clinical safety and performance summaries and exhaustive benefit–risk analyses by integrating clinical data with risk management protocols (ISO 14971).. Ensured airtight traceability across data sources and evolving global medical device regulatory requirements, verifying compliance across multiple product lines.. Handled intensive quality control checks for formatting, references, and traceability matrices to consistently secure audit-ready documentation.. Coordinated directly with Regulatory, Clinical, and Development partners to align internal drafts, manage complex deliverable timelines, and successfully resolve or escalate identified compliance or risk concerns.. Actively participated in internal peer reviews to promote rigorous methodological consistency, regulatory template compliance, and seamless Notified Body interaction.