Post Market Surveillance (PMS) at Shoolin Inc. Mountlake Terrace, Washington
disABLEDperson Inc
Post Market Surveillance (PMS) Specialist
We are hiring a Post Market Surveillance (PMS) Specialist to support a global medical device client.
Location: Bothell, WA
Key Responsibilities:
- Develop and maintain PMS Plans and PMS Reports
- Prepare and update PSURs (Periodic Safety Update Reports)
- Conduct Periodic Quality Review Board Meetings
- Perform complaint trending, signal detection, and escalation
- Drive CAPAs related to post-market surveillance
- Facilitate Health Hazard Evaluations and risk assessments
- Support audits, inspections, and regulatory reporting
- Collaborate with cross-functional teams including R&D, Clinical Affairs, Medical Affairs, and Quality
Requirements:
- 4 to 8 years of experience in Post Market Surveillance within medical devices
- Strong knowledge of FDA regulations (21 CFR 803, 806, 820)
- Experience with ISO 13485 and ISO 14971
- Hands-on experience with PMS Reports, PSURs, Risk Management, and FMEA
- Experience in EU MDR regulated environments
Preferred Skills: Post-Market Surveillance, QMS, Regulatory Compliance, Risk Management, Data Analysis
Vacancy posted 16 hours ago
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