Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director)
Sanofi
Cambridge, MA
8 days ago
Job Description
The Global Regulatory Affairs Device Head will lead a team overseeing regulatory activities for Sanofi's combination product and medical device portfolio. This position plays a critical role in shaping product strategy and driving regulatory deliverables in a dynamic and innovative healthcare environment.
Key Responsibilities
Lead, supervise and coach a team of regulatory professionals
Contribute to strategy, planning, and execution of device regulatory deliverables
Oversee and review device regulatory strategies of the assigned team
Participate in peer reviews of device regulatory strategies
Support development and alignment of cross-product device regulatory positions
Act as the Regulatory Affairs–Devices lead on assigned project teams
Develop innovative and sustainable medical device regulatory strategies
Provide regulatory guidance and advice to development teams
Prepare and review regulatory design control deliverables
Lead global filing activities for medical devices
Contribute to product development planning
Identify and manage issues impacting submissions timelines
Ensure regulatory plans are monitored and communicated
Lead device related health authority interactions
Provide regulatory impact assessments for product changes
Engage with regulatory bodies to influence medical device industry standards
Required Qualifications
At least 10 years of experience in the global healthcare industry with relevant medical device / combination product regulatory experience
Bachelor's degree in a scientific or engineering discipline
Experience in managing people in either a project or functional context
Proven experience in drug/device combination product regulatory approvals
Ability to synthesize and critically analyze data from multiple sources
Ability to travel internationally
Preferred Qualifications
Master's degree or other post graduate degree in relevant field
Foundational understanding of Artificial Intelligence and impact on industry
Benefits & Perks
High-quality healthcarePrevention and wellness programsAt least 14 weeks' gender-neutral parental leaveOpportunities for career growth