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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