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 ...