Join Sanofi as a GRA Device Lead (Associate Director) and play a crucial role in shaping the future of medicine. In this impactful position, you'll oversee regulatory activities for innovative diagnostics and collaborate with cross-functional teams to drive progress in drug discovery and development.
Key Responsibilities
Serve as GRA-Devices lead on assigned project teams
Develop innovative and sustainable medical device regulatory strategies
Prepare and review regulatory design control deliverables
Lead and support global filing activities for diagnostics
Support device-related health authority interactions
Provide regulatory impact assessments for proposed product changes
Identify and manage issues impacting submission timelines
Contribute to internal regulatory processes and procedures
Engage with regulatory bodies and industry groups
Required Qualifications
M.S. degree in a scientific or engineering discipline with 6 years regulatory experience or B.S. with 8 years regulatory experience
At least 3 years of relevant diagnostics regulatory experience
Proven experience with in-vitro diagnostics regulatory strategies and approvals
Understanding of global regulatory requirements for in-vitro diagnostics
Basic understanding of regulations and guidelines related to drug development
Preferred Qualifications
At least 10 years in the global healthcare industry
Ability to synthesize and critically analyze data from multiple sources
Dynamic personality, ability to think outside the box
Excellent communication and influencing skills
Strong interpersonal skills
Benefits & Perks
International work environmentStructured onboarding and trainingCareer path development supportWide range of health and wellbeing benefits including high-quality healthcareAt least 14 weeks’ gender-neutral parental leave