Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director)
Sanofi
Cambridge, MA
1 month ago
Job Description
Join Sanofi as the Global Regulatory Affairs Device Head for Specialty Care Devices. In this pivotal role, you will lead a diverse team in shaping the regulatory landscape for innovative medical device technologies. Collaborate closely with cross-functional stakeholders to accelerate product development and ensure compliance in a dynamic 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 of regulatory positions and dossier templates
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
Identify and manage issues affecting submission timelines
Engage with regulatory bodies to influence 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
Proven experience in drug/device combination product regulatory approvals
Ability to travel internationally
Preferred Qualifications
Master's degree or other post graduate degree in a relevant field
Foundational understanding of Artificial Intelligence and its impact on the industry
Experience in managing people in either a project or functional context
Benefits & Perks
High-quality healthcarePrevention and wellness programsAt least 14 weeks’ gender-neutral parental leaveCareer growth opportunities