Job details

Director, Post-Market Surveillance and Vigilance

Position Summary & Responsibilities:

This role can be based in either the St Louis, MO, Salt Lake City, UT or Durham, NC areas and will be responsible for the management of the Microbiology Vigilance Operational Team (VOT). In this role you will be accountable of the management of the Vigilance process, with direct responsibility for review and approval of Incident reporting decisions in the US. Responsible for the management of the Field action board process for all Microbiology product lines and be the key contact for competent authorities on vigilance and field action activities. You will be the responsible party for communication with FDA on FSCAs, MDRs, terminations and all follow-up. An ideal candidate will come from a direct vigilance or correction and removal role within the medical device industry having worked with software, reagents and laboratory instrumentation.

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 experience in Quality Assurance and/or Regulatory & Quality Compliance, with 3+ years of dedicated experience in Vigilance, Field Corrective Actions, and/or Post-Market Surveillance.
- Master's Degree with 6+ years of experience in Quality Assurance and/or Regulatory & Quality Compliance, with 3+ years of dedicated experience in Vigilance, Field Corrective Actions, and/or Post-Market Surveillance also accepted
3+ years of managerial experience also required.
Experience in the medical device or pharmaceutical industry preferred - FDA exposure is a huge plus
ISO 13485 and/or 9001 experience is a plus
Trackwise Digital 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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Pierre BOULUD

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Average salary estimate

$135000 / YEARLY (est.)

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$120000K

$150000K

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What You Should Know About Director, Post-Market Surveillance and Vigilance, bioMérieux

As the Director of Post-Market Surveillance and Vigilance at bioMérieux, you will take the helm of the Microbiology Vigilance Operational Team, driving crucial vigilance processes forward. Based in either St. Louis, MO, Salt Lake City, UT, or Durham, NC, you'll play an integral role in managing incident reporting decisions in the US and overseeing the Field Action Board process for all Microbiology product lines. Communication is key, as you’ll be the primary liaison for competent authorities regarding vigilance and field action activities. Your expertise will also be vital in communicating with the FDA on various matters like Field Safety Corrective Actions (FSCAs) and Medical Device Reports (MDRs). The ideal candidate comes with a strong background in vigilance, particularly within the medical device sector, ideally familiar with software, reagents, and laboratory instrumentation. You will not only lead the vigilance process but also contribute to Post Market Surveillance reports, manage regulatory communications, and ensure compliance with internal procedures. Your leadership will extend to managing a dedicated team, overseeing training, recruitment, and budget management while being a crucial participant in audits and continuous improvement projects. If you're ready to make significant contributions to patient safety and product quality, this role is for you!

Frequently Asked Questions (FAQs) for Director, Post-Market Surveillance and Vigilance Role at bioMérieux

What does the Director of Post-Market Surveillance and Vigilance role at bioMérieux entail?

The Director of Post-Market Surveillance and Vigilance at bioMérieux is responsible for managing the Microbiology Vigilance Operational Team. This includes oversight of incident reporting in the US, managing the Field Action Board process, and serving as the primary contact for regulatory authorities, including the FDA.