The Director will provide input to regulatory strategies and policies: assist in their development and ensure that regulatory strategies and policies are understood, compliant and successful and that Corporate regulatory processes are executed as planned.
Recruit, ensure staff development and provide input to human capital planning.
Plan and consolidate resources for next budget and manage approved budget.
Continuously assess Project/Program output with consideration to evolving regulations;
Assess impact on resources and launch dates; adapt regulatory strategies and give feedback to Project/Programs/Unit.
Manage and monitor regulatory processes at Program/Unit/Franchise or area level to ensure timely execution.
Assist in the drafting and validate answers to questions in the interactions/negotiations with regulatory agencies or their representatives; review progress on applications; report on issues.
Review, analyze and report on the effectiveness of the regulatory processes (strategy, applications review with questions/answers, issues and problem resolution);
Consolidate feedback, share gained experience and develop improvement plans.
Management of Direct and indirect team members in St. Louis, MO & France.
Typical Studies-Experience, Skills and Qualifications:
Knowledge and understanding of regulatory requirements, guidance documents and processes (local/regional)
A minimum of 8 years of practice in the field of IVDs/MDs in an international environment.
Must have expert knowledge in Microbiology.
Developed knowledge of design and change controls.
Familiar with product profiles and technology, company organization and processes.
Familiar with FDA and European regulations.
At least 4 or more years in a management or leadership position
Travel required: Domestic & International – approx.. 10%
Position is physically located in St. Louis, MO.
Skills and Qualifications:
Experience in an international environment.
Complex issue analysis and problem solving.
Communicate to internal/external stakeholders and regulatory agencies or their representatives.
Influence, challenge and negotiate.
Risk based decision making.
Strategic mind set
Preferred but not required:
Basic knowledge of QMS requirements (ISO 13485, US QSR and/or local GMP).
Participation in local/regional professional or trade organizations.
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity.
Scientific and technological innovation is at the heart of the bioMérieux strategy.
bioMérieux specializes in the in vitro diagnostics sector; we design, develop, produce
and market diagnosis systems for the medical and industrial application.
More than 40 years of experience in the field of infectious diseases allows bioMérieux,
a world leader in microbiology, to respond to major public... health issues, and affirm its
position as a key player in clinical diagnostics and industrial microbiologically quality control.
With a presence in over 150 countries the world headquarters is located in Marcy-l'Etoile,
France. North American locations include: Durham, NC, Lombard, IL & St. Louis, MO.
We offer a team based environment with exceptional benefits which includes an employee
friendly corporate culture, generous paid time off, pension plan, 401(k) with company
match, tuition assistance, comprehensive health plan and career development opportunities.