- Remote, United States
- Remote
- Full-time · Manager
- $232K–$365K per year
- 12+ years
Lead regulatory strategy and oversight for companion diagnostics and in vitro diagnostic products, managing a team of regulatory professionals and coordinating with global stakeholders.
Compensation
$231,900.00 - $365,000.00
Responsibilities
- Develop and oversee global regulatory strategies for companion diagnostics and IVD products
- Provide strategic and tactical CDx/IVD regulatory guidance
- Manage regulatory activities related to development, registration, approval, and lifecycle management
- Lead regulatory interactions with external partners and authorities
- Oversee preparation and approval of regulatory submissions
Requirements
- Bachelor’s degree in a biological science, chemistry, engineering, regulatory science, or a related discipline
- Nice to have: Diagnostics
- Nice to have: In Vitro Diagnostics (IVD)