Manager

Job Title: Post Market Surveillance (Medical Devices)Location: Pune, IndiaExperience: 10+ years of experience in drafting and managing Post-Market Surveillance (PMS) reports for Medical DevicesQualification:- Graduate in Biomedical Engineering, Pharmacy, or - Postgraduate in Life Sciences (or equivalent)Role SummaryPost 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 for international regulatory submissions - Post Market Surveillance - Medical Affairs - Regulatory Affairs - Risk Management - Sales & MarketingEssential Skills- Strong ability to assess technical, 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

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