Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director)
Sanofi
Morristown, NJ
1 month ago
Job Description
As the Global Regulatory Affairs Device Head at Sanofi, you will lead a diverse team focused on regulatory activities for innovative combination products and medical devices. This role is pivotal in shaping regulatory strategies that impact patient care and support the development pipeline of cutting-edge medical technologies.
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
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 regulatory design control deliverables
Lead and support global filing activities for medical devices
Identify and manage issues impacting submission timelines
Engage with relevant regulatory bodies and industry groups
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
Demonstrated strategic thinking and risk assessment proficiency
Ability to travel internationally
Preferred Qualifications
Master's degree or other post graduate degree in 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 healthcareWellness programsAt least 14 weeks’ gender-neutral parental leaveOpportunities for career growth and developmentSupportive team environment