GRA Device Lead (Associate Director) - Digital Health
Sanofi
2 months ago
Remote friendly (Cambridge, MA)
United States
Corporate Functions
Main Responsibilities
- Serve as GRA Device Lead for digital health technologies (DHTs) and software as a medical device (SaMDs) on assigned project teams (early phase, late stage and marketed products)
- Provide regulatory guidance and advice to the Global Regulatory Team (GRT) and cross-functional teams
- Develop and execute 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 interactions
- Identify DHT regulatory acceleration opportunities and regulatory risks; propose risk mitigations with the GRT
- Identify and manage issues and opportunities impacting submissions timelines; ensure appropriate communication, resolution, and escalation
- Lead global filing and lifecycle management activities for device submissions/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
- Support 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 as needed
- Participate in development and monitoring of the global regulatory environment; update standards and processes related to device regulations
- Contribute to a harmonized “One Sanofi” regulatory voice through participation in device committees/forums
- Support operational and compliance activities; execute regulatory submission planning (content plans, tracking, communications, document management)
- Contribute to internal regulatory processes and procedures for DHTs
- Accountable for regulatory assessment for DHT due diligence activities as applicable
May serve as Device Global Regulatory Lead (dGRL) leading a Device GRT (additional responsibilities)
- Fully accountable decision maker for development and execution of global regulatory strategies for products
- Lead the Device GRT; align team on mission, prioritization, objectives, and expectations for device regulatory strategy (including global labeling strategy)
- Ensure internal and external alignment/communication as “one GRA voice” to advocate regulatory position; share outcomes with GRT and cross-functional partners
- Single GRA point of contact for the DHTs program and represent GRA at Device Team, Global Project Team, and internal governance committees
Qualifications & Requirements
- 8+ years relevant pharmaceutical/biotechnology/medical device industry experience
- 5+ years Device/DHTs regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions
Required/Preferred Skills & Technical Knowledge
- Ability to develop device regulatory strategy to support implementing DHTs into clinical trials (digital endpoints) and SaMD development; proficiency preparing regulatory documentation using standard submission processes
- Understanding of clinical development, device (including design controls), manufacturing processes, and regulatory requirements in major markets
- Working knowledge of technical/industry standards: software development lifecycle, design controls, labeling, software documentation, risk management, clinical evaluations, usability
- Ability to synthesize and critically analyze data from multiple sources
- Ability to work effectively in a matrix environment with R&D, Device, Manufacturing, and Quality teams
- Business acumen plus strong leadership, influencing, and persuasive negotiation skills
- Strategic thinking, initiative, change-agent leadership, and risk assessment proficiency; ability to translate business objectives into actionable project strategies
- Bachelor’s degree in a scientific or engineering discipline; graduate degree preferred
- Strong written/verbal communication and influencing skills; fluency in English
- Ability to manage multiple projects in a fast-paced hybrid environment (60% on-site) and openness to learning/growth
Benefits (explicitly stated)
- Wide range of health and wellbeing benefits, including high-quality healthcare and prevention/wellness programs
- At least 14 weeks’ gender-neutral parental leave
Application instructions
- None stated
- Serve as GRA Device Lead for digital health technologies (DHTs) and software as a medical device (SaMDs) on assigned project teams (early phase, late stage and marketed products)
- Provide regulatory guidance and advice to the Global Regulatory Team (GRT) and cross-functional teams
- Develop and execute 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 interactions
- Identify DHT regulatory acceleration opportunities and regulatory risks; propose risk mitigations with the GRT
- Identify and manage issues and opportunities impacting submissions timelines; ensure appropriate communication, resolution, and escalation
- Lead global filing and lifecycle management activities for device submissions/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
- Support 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 as needed
- Participate in development and monitoring of the global regulatory environment; update standards and processes related to device regulations
- Contribute to a harmonized “One Sanofi” regulatory voice through participation in device committees/forums
- Support operational and compliance activities; execute regulatory submission planning (content plans, tracking, communications, document management)
- Contribute to internal regulatory processes and procedures for DHTs
- Accountable for regulatory assessment for DHT due diligence activities as applicable
May serve as Device Global Regulatory Lead (dGRL) leading a Device GRT (additional responsibilities)
- Fully accountable decision maker for development and execution of global regulatory strategies for products
- Lead the Device GRT; align team on mission, prioritization, objectives, and expectations for device regulatory strategy (including global labeling strategy)
- Ensure internal and external alignment/communication as “one GRA voice” to advocate regulatory position; share outcomes with GRT and cross-functional partners
- Single GRA point of contact for the DHTs program and represent GRA at Device Team, Global Project Team, and internal governance committees
Qualifications & Requirements
- 8+ years relevant pharmaceutical/biotechnology/medical device industry experience
- 5+ years Device/DHTs regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions
Required/Preferred Skills & Technical Knowledge
- Ability to develop device regulatory strategy to support implementing DHTs into clinical trials (digital endpoints) and SaMD development; proficiency preparing regulatory documentation using standard submission processes
- Understanding of clinical development, device (including design controls), manufacturing processes, and regulatory requirements in major markets
- Working knowledge of technical/industry standards: software development lifecycle, design controls, labeling, software documentation, risk management, clinical evaluations, usability
- Ability to synthesize and critically analyze data from multiple sources
- Ability to work effectively in a matrix environment with R&D, Device, Manufacturing, and Quality teams
- Business acumen plus strong leadership, influencing, and persuasive negotiation skills
- Strategic thinking, initiative, change-agent leadership, and risk assessment proficiency; ability to translate business objectives into actionable project strategies
- Bachelor’s degree in a scientific or engineering discipline; graduate degree preferred
- Strong written/verbal communication and influencing skills; fluency in English
- Ability to manage multiple projects in a fast-paced hybrid environment (60% on-site) and openness to learning/growth
Benefits (explicitly stated)
- Wide range of health and wellbeing benefits, including high-quality healthcare and prevention/wellness programs
- At least 14 weeks’ gender-neutral parental leave
Application instructions
- None stated