Manager

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
• Strong 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