Manager, Post-Market Surveillance and Complain Handling

InspireMD•Miami, FL

8d•Hybrid

About The Position

The Manager, Post‑Market Surveillance & Complaint Handling is responsible for leading and maintaining InspireMD's post‑market surveillance and complaint handling processes in compliance with FDA regulations, ISO 13485, and applicable global vigilance requirements. This role owns end‑to-end complaint management, including intake, investigation oversight, reportability determination, regulatory reporting, trending, and closure. The position serves as a key quality and regulatory interface, ensuring timely, accurate, and compliant handling of post‑market data to support patient safety, regulatory compliance, and continuous improvement.

Requirements

Bachelor's degree in science, engineering or related field.
5+ years of experience in a complaint handling role within the medical device industry.
Strong problem-solving skills with the ability to conduct root cause analysis and implement corrective actions.
Experience in complaint intake and reportability of class III devices.
Strong understanding of quality management systems, regulatory requirements, and industry best practices.
Strong communication skills, both written and verbal.
Detail-oriented with the ability to manage multiple tasks and meet deadlines.
Ability to work independently and collaboratively in a small team environment.

Responsibilities

Own and manage the post-market surveillance and complaint handling process, from intake through investigation, regulatory reporting, and closure.
Review and assess incoming complaints to determine reportability under FDA MDR, vigilance, and other applicable regulatory requirements.
Prepare, submit, and track FDA Medical Device Reports (MDRs) and other regulatory notifications, ensuring accuracy and timeliness.
Coordinate collection of missing information from reporters and manage product return and analysis workflows in collaboration with Engineering and Operations.
Ensure complaint files are complete, accurate, and inspection-ready at all times.
Perform and oversee complaint trending and post-market signal detection, escalating potential safety or compliance concerns as appropriate.
Develop, review, and maintain SOPs and work instructions related to complaint handling and post-market surveillance.
Support internal audits, FDA inspections, and notified body audits related to post-market activities.
Partner cross-functionally with Regulatory Affairs, Clinical, Engineering, and Manufacturing to support investigations, CAPAs, and risk management activities.
Track and report key quality metrics to support management review and continuous improvement initiatives.