Global Regulatory Affairs Device Lead (Associate Director)

Role Summary

Global Regulatory Affairs (GRA) Device Lead (Associate Director) drives global regulatory strategies for medical device and combination product programs within the Sanofi GRA Device team. Location: Morristown, NJ or Cambridge, MA or Framingham, MA. This role leads regulatory submissions, guides health authority interactions, and influences product approvals across development and post-marketing stages, collaborating with cross-functional teams across R&D, Device, Manufacturing, and Quality. The position may serve as the Device Global Regulatory Lead (dGRL) and lead a Device GRT, acting as the primary GRA contact for medical device programs.

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
• Identifies medical device regulatory acceleration opportunities and regulatory risks, and proposes thoughtful risk mitigations in collaboration with the GRT
• Identify and manage issues and opportunities that impact submissions timelines; ensures 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 global regulatory strategies for their products to meet corporate and business objectives
  • Leads the Device GRT, fostering team performance by aligning 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 and shares outcomes with the GRT and cross-functional partners as appropriate
  • 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: Demonstrate strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall business objectives into actionable project strategies
• 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 and execution for medical devices and device components of combination products
• Health Authority interactions and regulatory submissions
• Cross-functional collaboration across R&D, Device, Manufacturing, and Quality
• Leadership, influencing, and negotiation capabilities
• Strategic thinking and risk assessment proficiency
• Strong written and verbal communication and ability to influence stakeholders
• Ability to synthesize data from multiple sources and translate into regulatory strategies

Education

• Bachelor's degree in a scientific or engineering discipline. Graduate degree preferred.