Global Regulatory Affairs Device Lead (Associate Director)

Role Summary

Global Regulatory Affairs Device Lead (Associate Director) drives global regulatory strategies for medical device and combination products, collaborating with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and influence product approvals through strategic negotiations with health authorities worldwide. The role supports a wide range of combination products and devices, preparing high-quality regulatory submissions and ensuring compliance across the product lifecycle.

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 part of combination products elements
• 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 thoughtful risk mitigations in collaboration with the GRT
• Identify and manage issues and opportunities that impact submissions timelines; ensure appropriate communication, resolution and/or escalation as needed
• Lead global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissions
• Liaises with device, clinical, manufacturing, commercial, and other internal business 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 a regional/local regulatory lead and point of contact with medical device Health Authorities for projects/products in their remit, as needed
• Participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulations
• Contributes to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate device committees, forums
• Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, communication 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

• May serve as Device Global Regulatory Lead (dGRL) leading a Device GRT, which includes the additional responsibilities:
  • The dGRL is the fully accountable decision maker for the development and execution of robust global regulatory strategies to meet corporate objectives
  • Leads the Device GRT, aligns team on mission, prioritization, objectives and setting clear expectations for the device regulatory strategy, including a global labeling strategy
  • Ensures alignment and communication internally and externally as “one GRA voice” to advocate regulatory position to governance and committees
  • The dGRL is the single GRA point of contact for the medical device program and represents GRA at the Device Team, the Global Project Team, and internal governance committees

Qualifications

• Experience: 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 5+ years of medical device and/or combination product regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; 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 with technical/industry standards related to medical devices. Ability to synthesize and critically analyze data from multiple sources
• Collaboration Skills: Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Device, Manufacturing, and Quality teams. Demonstrates business acumen, strong leadership, influencing and persuasive negotiation skills
• Soft Skills: Strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall business objectives into actionable project strategies
• Education: Bachelor's degree in a scientific or engineering discipline. Graduate degree preferred
• Communication: Strong written and verbal communication and influencing skills, with fluency in English
• Adaptability: Capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site), with openness to learning and growth

Skills

• Regulatory strategy development
• Health Authority interactions and negotiations
• Regulatory submissions and lifecycle management
• Cross-functional collaboration and leadership
• Design controls and device/IVD development knowledge
• Risk assessment and mitigation

Education

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

Additional Requirements

• Hybrid work environment with approximately 60% on-site work