Senior Medical Writer (Medical Devices)

Location: Hyderabad

Work Mode: Work from Office Experience: 1–3 years

Notice Period: Immediate Joiners / Up to 30 Days

Industry: Medical Devices

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.