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Philips, a global leader in healthcare technology, is seeking a Post Market Surveillance (PMS) Specialist for its Pune location. This is a full-time opportunity for experienced professionals in medical devices who are passionate about post-market risk management, patient safety, and compliance with EU MDR and FDA regulations.
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If you have strong expertise in post-market surveillance plans, PSURs, risk assessments, and regulatory standards like ISO 13485 and ISO 14971, this role is a perfect match.
Key Responsibilities
As a Post Market Surveillance Specialist at Philips, you will:
- Develop and maintain PMS Plans and Reports.
- Prepare and update Periodic Safety Update Reports (PSURs).
- Conduct Quality Review Board meetings and generate periodic reports.
- Drive CAPAs related to post-market surveillance activities.
- Facilitate post-market risk assessments including health hazard evaluations.
- Collaborate with cross-functional teams (R&D, Clinical Affairs, Medical Affairs, Services, Complaint Handling).
- Ensure regulatory compliance with FDA, EU MDR, Canadian, and ISO standards.
- Support complaint trending, signal detection, and escalation.
- Provide PMS input into product development and risk management files.
Qualifications
To be the right fit, you should have:
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- Bachelor’s degree in Life Sciences, Biomedical Engineering, or related field.
- 4–8 years’ experience in Post Market Surveillance within FDA/EU-MDR regulated medical device environments (mandatory).
- Strong knowledge of 21 CFR Parts 803/806/820, ISO 13485, ISO 14971, EU MDR, Canadian Medical Device Regulations (mandatory).
- Excellent communication and stakeholder management skills.
- Ability to simplify processes, optimize workflows, and use automation tools.
- Product knowledge of Diagnostic X-rays (preferred).
Benefits of Working at Philips
- Hybrid work model: 3 days office, 2 days remote.
- Career growth in a global healthcare leader.
- Opportunities to collaborate with world-class teams.
- Be part of Philips’ mission to improve 3 billion lives by 2030.
How to Apply
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