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.
Manages the activities of the regulatory affairs staff in charge of Immunoassays, Microbiology and Molecular Biology (Argène). Directs the regulation process for products requiring approvals in Europe (CE-Marking), the US and China by ensuring that all necessary applications are filed and maintained. Assists in developing procedures to ensure regulatory compliance.
- Develop and implement harmonized regulatory operating guidelines/SOPs and common work practices/strategies within the team, supported by an efficient regulatory watch.
- Oversee and ensure compliance with regulatory procedures and work practices Review, analyze and report on the effectiveness of the regulatory processes (definition of KPIs).
- Provide expertise in translating regulatory requirements into practical, workable plans. Ensure timely execution of regulatory submissions in line with company strategies.
- Assist in drafting and validating answers to questions from regulatory authorities; monitor progress and escalate delays, problems as necessary. Proactively identify program issues and implement appropriate regulatory strategies to mitigate risks. Interface with regulatory authorities as needed.
- Attract and develop the relevant profiles and competencies for an efficient RA organization and ensure human capital planning.
- Maintain a positive team spirit and lead by ethical principles
- Establish, consolidate and monitor department budget.
Studies, Experience and Skills:
- Excellent knowledge and understanding of regulatory submissions with Health Authorities (FDA, Notified Bodies, Chinese NMPA) with more than 10 years of practice in the field of IVD’s/MDs in an international environment
- Strong scientific background (Master Degree, PhD…)
- Participation to local and/or international trade/associations
- Good understanding of QMS requirements (design and change control processes), as well as of audits/inspections
- Strong leadership and ability to provide vision
- Experienced with managing and coaching staff, and at ease with remote management within an international environment
- Capacity to influence, challenge and negotiate
- Excellent written and verbal communication skills. Clear communication to internal/external stakeholders at all levels and regulatory authorities
- Strategic and analytical thinker and problem-solver
- Planner with excellent organizational skills
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.