Post-Market Safety & Risk Lead (Medical Devices)

Katalyst CRO; Bothell (WA); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO seeks a PMS Specialist to manage post-market product safety surveillance and risk management initiatives. You will coordinate PMS plans, reports, and PSURs while driving CAPAs and ensuring regulatory alignment across FDA/EU-MDR environments.

The role requires 4–5 years in post-market surveillance, strong regulatory knowledge, and cross-functional collaboration with Medical Affairs, R&D, Services, and Complaint Handling. Expect a compliance-focused, fast-paced work setting.

Qualifications

• Bachelor's degree or equivalent required with focus on post-market surveillance and regulatory compliance.
• 4–5 years' experience in Post Market Surveillance within FDA/EU-MDR regulated Medical Device environments; proficiency in PMS plans/reports and risk assessment.
• Knowledge of medical device regulations and standards (e.g., 21 CFR Parts 803, 806, 820; ISO 13485; ISO 14971; EU MDR; CanadianRegulations).

Responsibilities

• Manage activities related to post-market product safety surveillance and risk management including PMS plans and reports.
• Conduct Periodic Quality Review Board meetings and create Periodic Quality Review Reports.
• Prepare and update PSURs and provide CAPA ownership for PMS.
• Audit and inspection support and regulatory reporting input.
• Collaborate with cross-functional stakeholders to drive post-market risk assessment of issues.

Skills

Post-Market Surveillance

Regulatory knowledge

CAPA ownership

Risk assessment

Data analysis

Cross-functional collaboration

Project management

Education

Bachelor's degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent

Job description

Katalyst CRO seeks a PMS Specialist to manage post-market product safety surveillance and risk management initiatives. You will coordinate PMS plans, reports, and PSURs while driving CAPAs and ensuring regulatory alignment across FDA/EU-MDR environments.

The role requires 4–5 years in post-market surveillance, strong regulatory knowledge, and cross-functional collaboration with Medical Affairs, R&D, Services, and Complaint Handling. Expect a compliance-focused, fast-paced work setting.