Product Monitoring Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Manage product complaints and conduct post-market surveillance in alignment with ISO 13485:2016, MDSAP, EU MDR, and other relevant regulations.

• Lead a team and ensure adequate resources are available to meet the responsibilities related to complaint handling and post-market surveillance.

⛳️ Requirements

• Offer leadership in the processes of complaint handling and post-market surveillance.

• Ensure that complaints are accurately documented and resolved promptly.

• Develop and track Key Performance Indicators (KPIs), reporting on the effectiveness of complaint management and post-market surveillance to executive management through Quality System Management Reviews.

• Conduct trend analyses and facilitate monthly Product Performance Management (PPM) meetings.

• Oversee and review device Vigilance Reports for the US, Canada, Australia, and/or Europe, coordinating responses to regulatory bodies as necessary.

• Manage Post Market Surveillance activities, ensuring that complaints, vigilance, and annual reports (including PSUR) adhere to regulations and established procedures.

• Compile and present detailed reports on product performance as required.

• Assist with Health Hazard Evaluations (HHEs).

• Serve as Subject Matter Expert (SME) for complaint handling and post-market surveillance during audits and regulatory inspections.

• Conduct periodic reviews of regulatory intelligence to ensure procedures remain current.

• Complete literature reviews as needed, assessing to identify related complaints or adverse events, and maintain a record of weekly reviews in compliance with regulations.

• Supervise product monitoring analysts.

🏝️ Benefits

• Medical, Dental, Vision Insurance

• Life/AD&D

• Short- and Long-Term Disability

• 401(K) with large company match

• Health Saving Account (HSA) and Flexible Spending Account (FSA) with company match

• Wellness Program

• Employee Assistance Program (EAP)

• Generous Paid Time Off (PTO)