GRA Device Lead (Associate Director) - Digital Health

Role Summary

The GRA Device Lead (Associate Director) - Digital Health drives global regulatory strategies for medical devices and digital health technologies. Location: Cambridge, MA or Morristown, NJ. This role leads regulatory planning across development stages, collaborates with cross-functional teams, and interfaces with health authorities worldwide to support product approvals and lifecycle management.

Responsibilities

• Serve as GRA Device Lead for DHTs and SaMDs 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 DHT, digital biomarkers/endpoints, and SaMD elements
• Define device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactions
• Identifies DHTs 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 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 DHTs
• Accountable for regulatory assessment for DHTs 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 & execution of creative, thoughtful, and robust global regulatory strategies for their products in order to meet corporate and business objectives.
• Leads the Device GRT, for fosters team performance by aligning 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 and shares outcomes to GRT and cross-functional partners as appropriate
• The dGRL is the single GRA point of contact for the DHTs 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 Device/DHTs regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions.
• Regulatory Expertise: Ability to develop device regulatory strategy to support implementing DHTs into clinical trials to enable the development of digital endpoints and supporting SaMD development. Proficiency in preparing regulatory documentation with standard submission processes.
• Technical Knowledge: Understanding of clinical development of medicinal products, device (including design controls), manufacturing processes, and regulatory requirements in major markets. Working knowledge with technical/industry standards related to e.g., software development lifecycle, design controls, labeling, software documentation, risk management, clinical evaluations, and usability. 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.

Education

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