Manager (Pune)

Manager (Pune)

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 in Biomedical Engineering , Pharmacy , or
Postgraduate in Life 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 for international regulatory submissions
Post Market Surveillance
Medical Affairs
Regulatory Affairs
Risk Management
Sales & Marketing

Essential 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
Robust attention to detail and regulatory documentation expertise

Preferred 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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