Post-Market Safety & Risk Lead – Medical Devices

Katalyst CRO; Cambridge (MA); Vor Ort; USD 110.000 - 190.000; Vollzeit

Zusammenfassung

Katalyst CRO is seeking a experienced Post Market Surveillance (PMS) Specialist in the United States. You will manage post-market product safety surveillance and risk management activities, coordinate with Medical Affairs, Clinical Affairs, R&D, and complaint handling, and drive PMS plans and PSURs end-to-end.

The role requires 4–8 years in PMS within FDA/EU-MDR regulated medical device environments, with knowledge of relevant regulations and standards.

Qualifikationen

• Bachelor's degree required with 4–5 years in Post Market Surveillance.
• Experience in FDA/EU-MDR regulated medical device environments and post-market risk assessment.
• Knowledge of medical device regulations and standards: 21 CFR Parts 803/806/820, ISO 13485, ISO 14971, EU MDR, SOR/98-282.

Aufgaben

• Manage activities related to post-market product safety surveillance and risk management.
• Serve as liaison across Medical Affairs, Clinical Affairs, R&D, Services, and Complaint Handling for end-to-end PMS/RM processes.
• Prepare and review PMS plans, PMS reports, PSURs, and CAPAs.
• Support regulatory reporting and risk management document preparation (risk matrices, PMPRR).
• Represent PMS in product development teams to ensure PMS deliverables are produced.

Kenntnisse

Post Market Surveillance

Regulatory knowledge

Risk assessment

Cross-functional collaboration

Project management

Ausbildung

Bachelor's Degree in Medical Sciences/Healthcare Management/Industrial Engineering/Supply Chain Management or equivalent

Jobbeschreibung

Katalyst CRO is seeking a experienced Post Market Surveillance (PMS) Specialist in the United States. You will manage post-market product safety surveillance and risk management activities, coordinate with Medical Affairs, Clinical Affairs, R&D, and complaint handling, and drive PMS plans and PSURs end-to-end.

The role requires 4–8 years in PMS within FDA/EU-MDR regulated medical device environments, with knowledge of relevant regulations and standards.