Post Market Surveillance (PMS) Specialist | Onsite Location: USA - (Bothell/Cambridge)| Contract

Job Title: Post Market Surveillance (PMS) Specialist

Onsite Location: USA - (Bothell/Cambridge)

Employment Type: Contract

Job Summary:
We are seeking an experienced Post Market Surveillance (PMS) Specialist with strong expertise in FDA/EU-MDR regulated Medical Device environments. The ideal candidate will be responsible for managing post-market product safety surveillance, risk management activities, complaint trending, regulatory reporting support, and cross-functional collaboration to ensure product safety and compliance.

Key Responsibilities:

• Create and maintain Post Market Surveillance (PMS) Plans and PMS Reports
• Prepare and update Periodic Safety Update Reports (PSURs)
• Conduct periodic Quality Review Board meetings and prepare review reports
• Drive CAPAs related to post-market surveillance activities
• Facilitate post-market risk assessments, issue impact assessments, and health hazard evaluations
• Support complaint trending investigations, signal assessments, and escalations
• Collaborate with cross-functional teams including R&D, Clinical Affairs, Medical Affairs, Engineering, Services, and Complaint Handling
• Review aggregate safety data and provide recommendations for escalation when required
• Support audit and inspection readiness activities
• Contribute to Risk Management documentation including risk management plans, risk matrices, FMEAs, and related reports
• Provide PMS and risk management input during product development activities
• Support regulatory reporting assessments and compliance activities

Required Qualifications:

• Bachelor s Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or related field
• 4 8 years of experience in Post Market Surveillance within FDA/EU-MDR regulated Medical Device environments
• Strong experience with PMS plans/reports and post-market risk assessments
• Detailed knowledge of medical device regulations and standards including:
  • 21 CFR Parts 803, 806, and 820
  • ISO 13485
  • ISO 14971
  • EU MDR
  • Medical Device Directives and related global regulatory standards

Preferred Skills:

• Post-Market Surveillance Processes
• Quality Management Systems (QMS)
• Risk Management & Health Hazard Evaluation
• Complaint Handling & Signal Assessment
• Regulatory Compliance
• Technical Documentation
• Quality Assurance (QA)
• Data Analysis & Reporting
• Cross-functional Collaboration
• Project Management