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 r esponsible 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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