What are the responsibilities and job description for the Post Market Surveillance (PMS) Specialist | Onsite Location: USA - (Bothell/Cambridge)| Contract position at Anagha Techno Soft?
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