Medical Writer Medical Devices

Roles & Responsibilities

• Author, review, and approve Clinical Evaluation Reports (CER)
• Prepare PSUR, PMCF, PMS Plans, Trend Reports, and other post-market surveillance documents
• Ensure compliance with EU MDR, global regulatory guidelines, and internal SOPs
• Conduct literature reviews and clinical data analysis for medical devices
• Collaborate with Regulatory Affairs, Quality, and cross-functional teams
• Support global regulatory submissions and product lifecycle management
• Maintain high documentation quality and regulatory compliance standards

Qualification

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

Experience

• Mandatory experience in medical device regulatory medical writing
• Hands-on exposure to CER, PSUR, PMCF, PMS, and Trend Reports
• Experience working with global medical device regulatory requirements

Skills

• Strong understanding of EU MDR and post-market surveillance regulations
• Excellent scientific and regulatory writing skills
• Ability to analyze clinical and literature data
• Strong attention to detail and documentation accuracy
• Good communication and cross-functional collaboration skills
• Willingness to relocate to Pune and work from office

About the Organisation

Wipro is a leading global information technology, consulting, and business process services company with a strong presence in healthcare and life sciences. The organization supports global medical device and pharmaceutical clients through high-quality regulatory, clinical, and compliance solutions, offering professionals exposure to international regulations, complex projects, and long-term career growth.