Develop, implement, and lead the regulatory regional strategy, in alignment with company goals, for new and sustaining ZOLL Resuscitation products and features.
The annual salary for this position is:
$101,600.00 to $152,400.00
This position is eligible for an annual bonus in accordance with the company's bonus plan.
- Develop and successfully implement regional regulatory strategies for new and sustaining products/features that result in device approval.
- Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
- Provide strategic regional regulatory perspective during the development, review, and approval of internal and external documentation to support the development and commercialization of assigned product(s).
- Work with RA regional and product teams to ensure that regulatory requirements are appropriately considered and accounted for in programs and projects.
- Author and prepare submittals of IDEs, 510(k), PMAs, Technical Files or Design Dossiers, and other pertinent regional device applications.
- Bachelor's Degree required
- Advanced Degree preferred
- Nice to have: Regulatory Affairs Certification
- Nice to have: electro cardiology
- Nice to have: defibrillation
CHARGE D'AFFAIRES REGLEMENTAIRES DISPOSITIFS MEDICAUX - H/FLaboratoires Théa S.A.S. · Clermont-Ferrand, France