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Description

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 plusISO 13485 and/or 9001 experience is a plus Trackwise Digital experience is a plusExperience managing teams in multiple locations is a plus Experience with Microsoft suite of tools is a plusThis role is anticipating 15% travel (domestic and/or international)#LI-US

BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).