Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director)
Sanofi
Morristown, SD
1 month ago
Job Description
Join Sanofi as the Global Regulatory Affairs Device Head to lead a dynamic team focused on innovative combination products and medical devices. This role involves strategic oversight, team leadership, and regulatory guidance, making a significant impact on the development of cutting-edge healthcare solutions.
Key Responsibilities
Lead and supervise a team of regulatory professionals
Contribute to strategy and execution of device regulatory deliverables
Oversee device regulatory strategies and participate in peer reviews
Act as the Regulatory Affairs–Devices lead on project teams
Develop innovative medical device regulatory strategies
Prepare regulatory design control deliverables and lead global filing activities
Engage with regulatory bodies to influence industry standards
Required Qualifications
At least 10 years of experience in the global healthcare industry
Relevant medical device / combination product regulatory experience
Bachelor’s degree in a scientific or engineering discipline
Preferred Qualifications
Master's degree or other post graduate degree in relevant field
Foundational understanding of Artificial Intelligence
Experience in managing people in a project or functional context
Proven experience in drug/device combination product regulatory approvals
Benefits & Perks
High-quality healthcarePrevention and wellness programsAt least 14 weeks’ gender-neutral parental leave