Join our Talent Network
Skip to main content

VP Global Regulatory Affairs

Location: Saint Louis, United States
Position Type: Unfixed Term
Job Function: Regulatory Affairs

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

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.

 

Position Summary:

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.

 

Responsibilities:

  • 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.

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. 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 BioMérieux’s or its affiliates’ 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).

Share: share to e-mail

Similar Jobs

Senior Regulatory Affairs Specialist

Saint Louis, United States
Regulatory Affairs

Staff Regulatory Affairs Specialist

Saint Louis, United States
Regulatory Affairs

VP Global Regulatory Affairs

Saint Louis, United States
Regulatory Affairs