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, where you will lead a team in shaping regulatory strategies for innovative medical devices and combination products. Your expertise will be pivotal in navigating complex regulatory landscapes, ensuring compliance, and driving product development that ultimately improves patient outcomes.
Key Responsibilities
Lead and supervise a team of regulatory professionals
Contribute to strategy, planning, and execution of device regulatory deliverables
Oversee and review device regulatory strategies
Participate in peer reviews of device regulatory strategies
Support development and review of cross-product regulatory positions
Act as the Regulatory Affairs–Devices lead on assigned project teams
Develop innovative medical device regulatory strategies
Provide regulatory guidance to development teams
Prepare and review regulatory design control deliverables
Lead global filing activities for medical devices
Contribute to product development planning
Manage issues impacting submissions timelines
Lead health authority interactions
Provide regulatory impact assessments for product changes
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
Experience in managing people in 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
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 leave