Medical Writer (Medical Devices)

Role & Responsibilities
• Author, review, and approve Clinical Evaluation Reports (CER) in compliance with EU MDR
• Prepare and maintain Periodic Safety Update Reports (PSUR)
• Develop Post-Market Clinical Follow-up (PMCF) plans and evaluation reports
• Create Trend Reports and other post-market surveillance documentation
• Ensure compliance with global medical device regulations in regulatory documents
• Collaborate with cross-functional regulatory, clinical, and quality teams
• Maintain document traceability, version control, and audit readiness
• Support regulatory submissions and responses to health authority queries

Qualification
• Graduate in Pharmacy or Biomedical Engineering, OR
• Post-Graduation in Life Sciences

Experience
• 2 to 15 years in medical device medical writing
• Proven hands-on experience in CER, PSUR, PMCF, and post-market documentation

Skills
• Strong understanding of EU MDR, post-market surveillance, and regulatory writing standards
• Experience with regulatory document creation and management
• Excellent written communication skills
• Ability to collaborate effectively across teams

About the Company
• Hiring through Wipro
• Pune-based, multinational organization
• Focused on global medical device regulatory projects and post-market surveillance