Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director)
Sanofi
Morristown, NJ
5 days ago
Job Description
Join Sanofi as the Global Regulatory Affairs Device Head for Specialty Care, where you'll lead a team shaping the future of medical devices and combination products. You will play a pivotal role in regulatory strategy, collaborating with cross-functional teams to bring innovative solutions to market, all while fostering a culture of excellence and compliance.
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
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
Lead and/or support global filing activities for medical devices
Support establishment of internal regulatory processes
Engage with 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
Experience in managing people in either a project or functional context
Proven experience in drug/device combination product regulatory approvals
Demonstrate strategic thinking and risk assessment proficiency
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 its impact on the industry
Benefits & Perks
High-quality healthcarePrevention and wellness programsAt least 14 weeks’ gender-neutral parental leaveOpportunities for career growth and development