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