Post-Market Safety & Risk Management Lead

Katalyst CRO; Cambridge (MA); On-site; USD 90,000 - 140,000; Full time

Job summary

Katalyst CRO seeks a Post Market Surveillance Specialist to lead safety surveillance and risk management across Medical Affairs, Clinical, R&D, Services and Complaint Handling. You will ensure PMS and RM processes are executed end-to-end, review aggregate data, and escalate as needed.

Responsibilities include creating PMS plans/reports, PSUR preparation, CAPA ownership, and cross-functional collaboration to meet FDA/EU MDR requirements.

Qualifications

• 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 PMS plans/reports and post-market risk assessment.
• Knowledge of medical device regulations and standards such as 21 CFR 803/806/820, ISO 13485, ISO 14971, EU MDR, and related Canadian/European regulations.

Responsibilities

• Create and maintain PMS Plans and PMS Reports.
• Conduct Periodic Quality Review Board Meetings and generate Periodic Quality Review Reports.
• Prepare and update PSURs; provide CAPA ownership for post-market surveillance.
• Support risk management activities including health hazard evaluations and risk assessments.

Skills

Post-Market Surveillance

Quality Management Systems

Regulatory Requirements

Technical Documentation

Project Management

Quality Assurance

Data Management

Business Acumen

Education

Bachelor's Degree

Job description

Katalyst CRO seeks a Post Market Surveillance Specialist to lead safety surveillance and risk management across Medical Affairs, Clinical, R&D, Services and Complaint Handling. You will ensure PMS and RM processes are executed end-to-end, review aggregate data, and escalate as needed.

Responsibilities include creating PMS plans/reports, PSUR preparation, CAPA ownership, and cross-functional collaboration to meet FDA/EU MDR requirements.