Post Market Surveillance Specialist

Responsibilities 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 and PMS Reports. Serve 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). Review and prepare reports on aggregate data and provide recommendations for further escalation. Prepare and 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 and/or other regulators, and provide input to establish metrics. Facilitate post-market risk assessment including issue impact assessments and health hazard evaluations; support audit and inspection activities; own and drive CAPAs on post-market surveillance. Participate in Periodic Quality Review Board Meetings and prepare Periodic Quality Review Reports; prepare and update PSURs; support signal detection, trending investigations, and escalation as part of PMS processes. Represent PMS interests in multi-disciplinary product development teams and ensure PMS deliverables are developed and completed throughout the design process. Collaborate with cross-functional stakeholders (R&D, Services, Complaint handling, Medical Affairs, Clinical Affairs, Engineering, etc.) to drive meaningful post-market risk assessment of issues. Post Market Surveillance (PMS) Establish standard PMS processes across business units and ensure consistent PMS plans for all products. Execute proactive surveillance (e.g., regulatory database searches, literature reviews) and reactive surveillance (e.g., complaints handling, field actions); ensure PMS Reports/PSURs are consistent for all products. Conduct periodic quality board meetings to review PMS data and take actions to keep products safe and compliant. Support complaint trending investigations, signal assessment, and escalation; integrate findings into PMS reports and risk management files. Patient Safety And Regulatory Reporting Collaborate with Data trending and analytics and Medical Affairs to monitor and assess safety signals and recommend actions. Assess product relationship to reported complaints; ensure standard regulatory reporting criteria for PMS activities; provide input to clinical conclusions for reporting to competent authorities. Enable timely and accurate post-market risk assessments to support correction and removal decisions. Risk Management Support standard risk management processes and facilitate post-market risk assessments including issue impact assessment and health hazard evaluations. Collaborate with cross-functional stakeholders to drive meaningful post-market risk assessment of issues. Support the preparation and/or review of risk management documents (risk management plans, risk matrix status reports, PPMRR, etc.). PMS And RM Input Into Product Development Represent PMS interests in multi-disciplinary teams during product development and ensure PMS deliverables are developed throughout the design process. Provide input on PMS-related product risk and quality issues during the development of new products. Qualifications Bachelor's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent. Minimum of 4-5 years of 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, 820; ISO 13485; ISO 14971; European Medical Device Directive (93/42/EEC); EU MDR; Canadian Medical Devices Regulation (SOR/98-282). 4-8 years of experience in Post Market Surveillance within FDA/EU-MDR regulated Medical Device environments with focus on post-market surveillance plans/reports and post-market risk assessment (mandatory). Detailed knowledge of relevant medical device regulations and standards (mandatory). Preferred Skills Post-Market Surveillance Mechanisms Quality Management Systems (QMS) Regulatory Requirements Technical Documentation Project Management Quality Assurance (QA) Data Management Business Acumen #J-18808-Ljbffr Katalyst CRO