Post Market Surveillance Specialist

About the role

You are responsible for managing activities related to post-market product safety surveillance and risk management. Serves as a liaison between Medical Affairs, Clinical Affairs, Research & Development, Services, and Complaint Handling to ensure Post Market Surveillance (PMS) and Risk Management (RM) processes are executed end-to-end (E2E).

Responsibilities

• Reviews and prepares reports on aggregate data and provides recommendation for further escalation.
• Prepare/review complaint trend analysis, product risk assessments including Health Hazard Evaluations, clinical evaluation reports, risk management reports and FMEAs.
• Affords assistance in benchmarking best practices with world-class organizations, interfaces with notified body, and/or other regulators, and provides input to establish metrics.
• The PMS Specialist is responsible for managing activities related to post-market product safety surveillance and risk management including:
• Creation and maintenance of PMS Plans.
• Creation and maintenance of PMS Reports.
• Conduct Periodic Quality Review Board Meetings and creation of Periodic Quality Review Reports.
• Preparation and update of PSURs.
• Audit and Inspection support.
• Own and effectively drive CAPAs on post-market surveillance.
• Facilitate Post Market Risk Assessment including Issue impact assessments, Health hazard evaluation, etc.

Requirements

• Bachelor's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.
• Minimum of 4-5 years' experience in Post Market Surveillance within FDA/EU-MDR regulated Medical Device environments with a focus on post-market surveillance plans/reports and post market risk assessment.
• Mandatory: Detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation (EU MDR), Canadian Medical Devices Regulation (SOR/98-282), etc.

Preferred Skills

• Post-Market Surveillance Mechanisms.
• Quality Management Systems (QMS).
• Regulatory Requirements.
• Technical Documentation.
• Project Management.
• Quality Assurance (QA).
• Data Management.
• Business Acumen.