GRA Device Lead (Associate Director) - Digital Health

Role Summary

GRA Device Lead (Associate Director) – Digital Health based in Cambridge, MA or Morristown, NJ. Lead global regulatory strategies for medical device and digital health technologies, collaborating with cross-functional teams to navigate regulatory landscapes, optimize product development and manufacturing processes, and influence product approvals through negotiations with health authorities worldwide.

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.
• Identify DHTs regulatory acceleration opportunities and regulatory risks, and propose risk mitigations in collaboration with the GRT.
• Identify and manage issues and opportunities that impact submissions timelines; ensure 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 Health Authorities for projects/products, as needed.
• Participate in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulations.
• Contribute to the development of a harmonized regulatory voice through participation in device committees and forums.
• Support operational and compliance activities for assigned deliverables, develop and execute regulatory submission planning, including 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 with additional responsibilities including strategic leadership, alignment of objectives, and governance communications.

Qualifications

• Experience: 8+ years in pharmaceutical/biotechnology/medical device industry with 5+ years of Device/DHT regulatory experience; experience contributing to regulatory filings and responding to Health Authority questions.
• Regulatory Expertise: Ability to develop device regulatory strategy to support DHTs in clinical trials and SaMD development; proficiency in regulatory documentation and standard submission processes.
• Technical Knowledge: Understanding of clinical development of medicinal products, device design controls, manufacturing processes, and regulatory requirements in major markets; familiarity with software development lifecycle, design controls, labeling, documentation, risk management, clinical evaluations, and usability.
• 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 leadership, and risk assessment with ability to translate business objectives into actionable 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 work environment (60% on-site).

Education

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