4C Drug safty Services

We’re Hiring: Senior Medical Writer (Medical Devices) Location: Hyderabad Work Mode: Work from Office Experience: 2.1 to 4 years Notice Period: Immediate Joiners / Up to 15 Days (Male Candidates) Industry: Medical Devices (PSUR and PMS experience is must) Key Responsibilities: Author and review clinical evaluation reports (CERs), clinical evaluation plans (CEPs), PMCF plans/reports, SSCPs, PSURs, and other safety documents for medical devices.Review safety data from clinical trials, post-market surveillance, complaints, and adverse events.Perform literature searches, data analysis, trend and hazard analysis, and summarize device-specific benefits and risks.Collaborate with cross-functional teams (Regulatory, Clinical, QA, Medical Affairs) and participate in client/regulatory interactions.Ensure compliance with EU MDR (MEDDEV 2.7, 2.12 series, ISO 14155) and internal standards.Support audits, inspections, and responses to regulatory queries.Prepare training decks, process improvement initiatives, and maintain knowledge of current regulations (MDCG, IMDRF, etc.). Act as a mentor to junior writers and support team knowledge sharing.Preferred Skills & Experience:1–3 years in medical device regulatory affairs or clinical documentation.Hands-on experience with PSURs, PMS reports, CERs, CEPs, PMCF, and MAUDE database.Strong understanding of medical device safety reporting and regulatory guidelines.Excellent analytical, writing, and communication skills; detail oriented.Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).Education:Bachelor’s or Master’s in Pharmacy, Life Sciences, Nursing, or related fields.B.Tech/M.Tech in Biomedical, Electronics, Mechanical Engineering also considered. Apply Now: hr@4cpharma.com Job Type: Full-time Pay: ₹40,000.00 - ₹50,000.00 per month Benefits: Flexible schedule Health insurance Provident Fund Work Location: Remote