Global Regulatory Affairs Device Lead (Associate Director)

Role Summary

The Global Regulatory Affairs (GRA) Device team leads regulatory strategy for medical devices, combination products, digital health and IVDs within Sanofi's portfolio. The GRA Device Lead drives global regulatory strategies across the product lifecycle, mentors cross-functional teams, and negotiates with health authorities worldwide to enable timely approvals and compliant submissions. This role collaborates across R&D, Device, Manufacturing, and Quality to prepare high-quality regulatory submissions and anticipate regulatory trends. Location options include Morristown, NJ; Cambridge, MA; or Framingham, MA.

Responsibilities

• Serve as GRA Device Lead on assigned project teams (early phase, late stage and marketed products)
• Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional teams
• Develop and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices and device portions of combination products
• Define device Health Authority interactions plan, lead device-related health authority interactions, and support cross-functional health authority interactions
• Identify medical device regulatory acceleration opportunities and regulatory risks, and propose risk mitigations in collaboration with the GRT
• Identify and manage issues and opportunities that impact submission timelines; ensure appropriate communication, resolution and escalation as needed
• Lead global filing and lifecycle management activities for device submissions and device aspects of medicinal product submissions
• Liaise with device, clinical, manufacturing, commercial, and other internal partners to enable successful regulatory outcomes
• Prepare, review and approve design control deliverables
• Contribute to product development and lifecycle management planning
• Provide regulatory impact assessments for proposed product changes
• May serve as regional/local regulatory lead and point of contact with medical device Health Authorities for projects/products in their remit
• Participate in the development and monitoring of the global regulatory environment and updating standards and processes related to device regulations
• Contribute to a harmonized, One Sanofi regulatory voice through device committees and forums
• Support operational and compliance activities for deliverables, develop and execute submission planning activities, including submission content plans, tracking, and document management
• Contribute to internal regulatory processes and procedures for medical devices
• Accountable for regulatory assessment for medical devices Due Diligence activities as applicable

Qualifications

• Experience: 8+ years in pharmaceutical/biotechnology/medical device industry with 5+ years in medical device and/or combination product regulatory experience; contributions to regulatory filings and regulatory strategy implementations; experience responding to Health Authority questions
• Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processes
• Technical Knowledge: Understanding of clinical development of medicinal products, device/IVD development (including design controls), manufacturing processes, and regulatory requirements in major markets; working knowledge of medical device standards; ability to synthesize and analyze data from multiple sources
• Collaboration Skills: Ability to work effectively in a matrix environment with R&D, Device, Manufacturing, and Quality teams; strong leadership, influencing and negotiation skills
• Soft Skills: Strategic thinking, initiative, change management, and risk assessment abilities; ability to align business objectives with project strategies
• Education: Bachelor's degree in a scientific or engineering discipline; graduate degree preferred
• Communication: Strong written and verbal communication and influencing skills; fluency in English
• Adaptability: Ability to manage multiple projects in a fast-paced, hybrid environment (60% on-site); openness to learning and growth

Skills

• Regulatory strategy development for medical devices and combination products
• Global health authority interactions and submissions management
• Cross-functional collaboration and influence
• Risk assessment and mitigation planning
• Design control and regulatory compliance
• Regulatory intelligence and environment monitoring

Education

• Bachelor’s degree in a scientific or engineering discipline; graduate degree preferred

Additional Requirements

• Adaptability to a fast-paced, hybrid work environment with on-site requirements (approximately 60%)

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