Manager, Healthcare

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