• Manage the Field Action process and approve the Field Action Board meeting decisions and all Field Action communications submitted to bioMérieux customers.
• Manage the Vigilance process and approve the Adverse Event decisions according to local regulations (FDA/ANSM).
• Contribute to the completion of Post Market Surveillance (PMS) reports in assigned region. Manage completion of Corporate QMS Indicators for sites in assigned regions.
• Manage information and communication with Regulatory Authorities; interact with regulatory authorities and represent bioMérieux when dealing with Regulatory Agencies.
• Ensure decisions and communications are in compliance with internal procedures and directives, and train, re-train or advise employees as required to ensure compliance. Stay abreast of regulatory changes, and manage the creation, review and revision of department procedures to ensure continuous improvement of department processes.
• Manage the Microbiology VOT team including training, budget management, GPS, and recruitment. Participate and support audits and inspections. Manage department projects as assigned.
• Be primary contributor to the audits MDSAP, Corporate Vigilance audits and potential CA inspections.
• Contribute to the quality road map projects and other continuous improvement projects.

Education, Skills, & Experience:

• Bachelor’s Degree with 8+ years of related experience in Vigilance Process and Reporting, Correction and Removal Processes, and/or Post-Market Surveillance.
  • 3+ years of managerial experience also required
• Experience in the medical device or pharmaceutical industry preferred
• Trackwise Digital experience is a plus
• FDA exposure is a huge plus
• ISO 13485 and/or 9001 experience is a plus 
• Experience managing teams in multiple locations is a plus 
• Experience with Microsoft suite of tools is a plus
• This role is anticipating 15% travel (domestic and/or international)

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