Senior Supervisor EU Post Market Surveillance

Job Description

Primary Function of Position:

The Post Market Surveillance Sr. Supervisor supports the Regulatory Department by supervising the team responsible for post market surveillance, maintaining, updating and reporting departmental metrics and approving potentially reportable complaints. The Sr. Supervisor leads, trains and develops the team members, and acts as an expert in complaint/vigilance investigation reporting.

Roles and Responsibilities:

• Distribute vigilance reports and Regulatory Additional Information (RAI) Requests
• Supervise the team responsible for post -market surveillance to ensure that vigilance reports and RAIs are timely and accurately submitted, investigation is completed and the decision regarding regulatory reporting is appropriately documented
• Maintain, update and report departmental metrics (EU monitoring, KPIs)
• Approve vigilance reports and RAIs
• Draft vigilance reports and RAIs as appropriate to support the team when necessary
• Prepare and send monitoring reports
• Act as an expert in complaint investigation/vigilance reporting:
• Evaluate documentation for completeness and consistency and assign additional actions as necessary
• Perform the assessment review and approve the records
• Assist with customer escalations as needed and provide training to internal and external stakeholders
• Support compliance of post-market surveillance processes to EU MDR and other evolving regulatory requirements
• Developing and executing training programs to educate company personnel on post-market surveillance processes as needed
• Cross-collaborate with other departments as necessary (e.g. US PMS Team, Engineering Team, Customer Service, Regulatory Affairs, intra-company distributors etc.)
• Prepare and send monitoring reports as required
• Act as a PMS Subject Matter Expert during site’s audits/ inspection as necessary

People Management

• Lead, train and develop team members

Additional activities

• Act as a PMS Subject Matter Expert during site’s audits/ inspection as necessary
• Lead Improvements projects and drive them to completion as necessary