Post Market Surveillance Engineer – Medical Device

Hiring:
Post Market Surveillance Specialist – Medical Device

We are looking for an experienced Post Market Surveillance (PMS) Specialist to support post-market activities for medical device products in the United States
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• 3+ years of experience in Post Market Surveillance, Medical Device Quality, Complaint Handling, or Regulatory Affairs
• Experience managing and evaluating medical device complaints
• Strong knowledge of Post Market Surveillance processes
• Experience with FDA Medical Device Reporting (MDR) requirements
• Knowledge of 21 CFR Part 803 and applicable FDA regulations
• Experience with complaint investigations, assessment, classification, and closure
• Strong understanding of CAPA and Quality Management Systems
• Experience performing Root Cause Analysis (RCA)
• Ability to assess complaints for regulatory reportability
• Experience with complaint trending and data analysis
• Ability to identify recurring product issues, safety signals, and emerging risks
• Knowledge of ISO 13485 requirements for medical device quality systems
• Working knowledge of ISO 14971 Risk Management
• Experience preparing PMS reports, trend reports, and regulatory documentation
• Familiarity with IMDRF coding and event classification
• Experience with QMS / Complaint Management systems such as Track Wise, Veeva, SAP, or similar platforms
• Ability to collaborate with Quality, Regulatory, Engineering, R&D, Manufacturing, and Clinical teams
• Strong technical writing, documentation, and analytical skills
• Ability to manage multiple investigations while meeting regulatory deadlines