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Job Title: Post Market Surveillance (Medical Devices) Location:Pune, India Experience:10+ years of experience in drafting and managing Post-Market Surveillance (PMS) reports for Medical Devices Qualification: Graduate inBiomedical Engineering ,Pharmacy , or Postgraduate inLife Sciences(or equivalent)Role Summary Post Market Surveillance will be responsible for leading and executing post-market surveillance activities for medical devices in compliance with global regulatory requirements. This role involves drafting, reviewing, and submitting PMS documentation, collaborating with cross-functional teams, and supporting regulatory authority interactions.Key Responsibilities Lead, draft, update, review, and maintain: PMS Plans PMS Reports / PSUR PRER Canada Summary Reports for Medical Devices Identify appropriate sources of relevant post-market and clinical data, including: Scientific literature Clinical data Medical and safety references Interpret, evaluate, and integrate data from multiple sources into regulatory-compliant documents Compile and submit accurate and complete clinical and post-market documentation forinternational regulatory submissions Post Market Surveillance Medical Affairs Regulatory Affairs Risk Management Sales & MarketingEssential Skills Strong ability to assesstechnical, clinical, and medical data Capability to analyze data and propose scientifically sound and compliant solutions Excellent written and verbal communication skills Strong attention to detail and regulatory documentation expertisePreferred Attributes Experience with global regulatory frameworks (EU MDR, Health Canada, US FDA, etc.) Ability to mentor, coach, and guide junior team members Strong stakeholder management and cross-functional collaboration skills