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Job Description
Join Sanofi as the GRA Device Lead, Associate Director, and play a pivotal role in shaping innovative medical devices and diagnostics. This position offers opportunities to support a diverse range of diagnostic projects and collaborate with cross-functional teams to drive regulatory strategies that meet global standards.
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 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 for diagnostics and medical devices
Engage with regulatory bodies to influence industry standards
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 and registration
Proven ability to work cross-functionally in a global environment
Preferred Qualifications
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
Strong organizational skills to multi-task in a fast-paced environment
Independently motivated and detail-oriented
Ability to travel internationally
Benefits & Perks
International work environmentStructured onboarding and trainingCareer path development supportOpportunities for international career pathsHealth and wellbeing benefits including high-quality healthcareAt least 14 weeks’ gender-neutral parental leave