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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CEO of bioMérieux

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

Looking to take your career to the next level in a dynamic and engaging environment? bioMérieux is on the hunt for a Director of Post-Market Surveillance and Vigilance. This position offers the flexibility to work from the bustling St. Louis, MO, scenic Salt Lake City, UT, or vibrant Durham, NC areas. In this pivotal role, you'll lead the Microbiology Vigilance Operational Team (VOT) while managing the entire vigilance process with a keen eye for detail. Your responsibilities will include overseeing the review and approval of incident reporting decisions in the US and managing the Field Action Board for all Microbiology product lines. You will serve as a primary contact for regulatory authorities, including the FDA, regarding Field Safety Corrective Actions (FSCAs) and Medical Device Reports (MDRs), ensuring that all communications are clear, compliant, and prompt. The ideal candidate will have a strong background in vigilance or corrective actions within the medical device sector, particularly with software, reagents, and laboratory instruments. Your leadership will be vital in training and mentoring your team while managing projects, audits, and inspections. With a Bachelor's or Master's degree in relevant fields and substantial experience in Quality Assurance, this role is perfect for forward-thinking professionals eager to contribute to continuous improvement and quality assurance initiatives. Ready to make an impact at bioMérieux? We're looking forward to your application!

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

What qualifications are needed for the Director of Post-Market Surveillance and Vigilance at bioMérieux?

To qualify for the Director of Post-Market Surveillance and Vigilance position at bioMérieux, candidates should hold a Bachelor's or Master's Degree related to Quality Assurance or Regulatory Compliance. Along with significant experience in Vigilance and Post-Market Surveillance, a minimum of 8 years in the field with at least 3 years in a managerial role is essential. Previous experience in the medical device industry, especially with FDA regulations, will give you a leg up.