Wipro is inviting applications for the position of Medical Writer – Medical Devices at its Pune location. This opportunity is ideal for professionals with experience in Clinical Evaluation Reports (CER), PSUR, PMCF, and post-market regulatory documentation for global medical device markets. The role is work from office (WFO) and open to candidates with 2 to 15 years of experience.

If you are a Pharmacy graduate, Biomedical Engineer, or Life Sciences post-graduate looking to advance your career in medical device regulatory writing, this role offers exposure to global regulations and high-impact documentation.

🧾 Key Responsibilities – Medical Writer (Medical Devices)

• Author, review, and approve Clinical Evaluation Reports (CER) in compliance with EU MDR
• Prepare and maintain PSUR (Periodic Safety Update Reports)
• Develop PMCF plans and PMCF evaluation reports
• Create Trend Reports and other post-market surveillance documentation
• Ensure regulatory documents align with global medical device regulations
• 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

🎓 Qualifications & Experience Required

• Minimum 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
• Strong understanding of EU MDR, post-market surveillance, and regulatory writing standards
• Willingness to relocate to Pune and work from office (WFO)

💼 Why Join Wipro?

• Work on global medical device regulatory projects
• Exposure to EU MDR and international regulatory frameworks
• Stable career growth in a leading multinational organization
• Collaborative work environment with experienced regulatory professionals
• Competitive compensation aligned with industry standards

📍 Job Location

Pune, Maharashtra (Work From Office)

💰 Salary (Indicative)

₹8,00,000 – ₹18,00,000 per annum
(Salary may vary based on experience, skills, and interview performance)

📩 How to Apply

📧 Interested and eligible candidates can share their updated resume at:
simran.sagar@wipro.com

⚠️ Only candidates with the mentioned qualifications and relevant experience are requested to apply.

Team: Dhaval Shah