A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 5,000 team members across 12 sites or subsidiaries, including Salt Lake City based BioFire Diagnostics. We believe in the power of diagnostics and bioMérieux sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health across the globe. Come be a part of our mission to help save lives.
Primary Purpose and Overall Objective of the Job:
- Responsible for the management of the microbiology Vigilance operational team (VOT) team.
- 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 products.
- Key contact for competent authorities on vigilance and field action activities. Be the responsible party for communication with FDA on FSCAs, MDRs, terminations and all follow-up.
- 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, PMP, 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 the quality road map projects and other continuous improvement projects.
Studies and Experience:
- Knowledge of compliance requirements, guidance documents and processes (local/regional) with 3-6 years of practice in the field of IVD/MD in an international environment.
- Developed knowledge of Vigilance Guidance Documents, FDA 806 & 803, MEDDEV Vigilance, QMS requirements (QSR820,ISO 13485, ISO 9001).
- Familiar with local regulatory agency organization, with company product profiles and technology,
- Participation in local professional/trade associations is preferred.
Skills and Qualifications:
- Analyze, understand regulatory requirements and identify solutions; provide directions for proper implementation.
- Leadership: Routine problem solving, develop rationale and justify position.
- Communication skills: work in an international environment and lead cross functional meetings, Communicate to internal stakeholders and regulatory agencies/conformity assessment body.
- Expertise in vigilance and Field actions: Considered as Expert that can develop and deliver training within the department and/or organization.
- Previous experience in Management role.
- Reliable attendance and punctuality is an essential job function required for this position.
Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 13,000 bioMérieux team members who already identify with these values!
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.