Post Market Surveillance Specialist

Responsibilities

• Manage activities related to post-market product safety surveillance and risk management.
• Serve as a liaison between Medical Affairs, Clinical Affairs, Research & Development, Services, and Complaint Handling.
• Review and prepare reports on aggregate data and provide recommendations for further escalation.
• Prepare/review complaint trend analysis, product risk assessments including Health Hazard Evaluations, clinical evaluation reports, risk management reports, and FMEAs.
• Assist in benchmarking best practices with world-class organizations, interface with notified bodies, or other regulators, and provide input to establish metrics.

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.
• 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.