GRA Device Associate- Digital Health
Sanofi
July 03, 2026
Remote friendly (Cambridge, MA)
United States
$122,250 - $176,583.33 USD yearly
Corporate Functions
Main Responsibilities:
- Partner with the Device Regulatory Lead on assigned projects.
- Provide regulatory guidance to the Global Regulatory Team (GRT) and cross-functional teams.
- Execute medical device regulatory strategies for DHTs, digital biomarkers/endpoints, and SaMD.
- Support device Health Authority interactions planning and interactions.
- Identify regulatory acceleration opportunities and risks; propose risk mitigations with GRT.
- Identify issues impacting submission timelines; manage communication, resolution, and escalation.
- Support global filing and lifecycle management for device submissions and device aspects of medicinal product submissions.
- Liaise with device, clinical, manufacturing, commercial, and other internal partners.
- Prepare/review design control deliverables.
- Contribute to product development/lifecycle planning and provide regulatory impact assessments for product changes.
- May serve as regional/local regulatory lead and Health Authority point of contact.
- Plan and manage regulatory submission activities (content plans, tracking, communications, document management).
- Contribute to internal regulatory processes/procedures for device.
Qualifications & Experience:
- Bachelor’s degree in a scientific/engineering discipline (graduate preferred).
- 5+ years industry experience (pharma/biotech/medical device) with 3+ years regulatory experience, including regulatory filings/strategy implementation and responding to Health Authority questions.
Required/Preferred Skills:
- Strong matrix work skills; business acumen; leadership/influencing and negotiation.
- Strong written/verbal communication; fluency in English.
- Ability to manage multiple projects in a fast-paced hybrid environment.
- Familiarity with device regulatory strategy for DHT clinical trials, standard submission processes, and regulatory documentation.
- Knowledge of clinical development, device/IVD development (design controls), manufacturing, and regulatory requirements; standards for software development lifecycle, labeling, documentation, risk management, clinical evaluations, and usability.
Benefits (as stated):
- Health and wellbeing benefits, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Partner with the Device Regulatory Lead on assigned projects.
- Provide regulatory guidance to the Global Regulatory Team (GRT) and cross-functional teams.
- Execute medical device regulatory strategies for DHTs, digital biomarkers/endpoints, and SaMD.
- Support device Health Authority interactions planning and interactions.
- Identify regulatory acceleration opportunities and risks; propose risk mitigations with GRT.
- Identify issues impacting submission timelines; manage communication, resolution, and escalation.
- Support global filing and lifecycle management for device submissions and device aspects of medicinal product submissions.
- Liaise with device, clinical, manufacturing, commercial, and other internal partners.
- Prepare/review design control deliverables.
- Contribute to product development/lifecycle planning and provide regulatory impact assessments for product changes.
- May serve as regional/local regulatory lead and Health Authority point of contact.
- Plan and manage regulatory submission activities (content plans, tracking, communications, document management).
- Contribute to internal regulatory processes/procedures for device.
Qualifications & Experience:
- Bachelor’s degree in a scientific/engineering discipline (graduate preferred).
- 5+ years industry experience (pharma/biotech/medical device) with 3+ years regulatory experience, including regulatory filings/strategy implementation and responding to Health Authority questions.
Required/Preferred Skills:
- Strong matrix work skills; business acumen; leadership/influencing and negotiation.
- Strong written/verbal communication; fluency in English.
- Ability to manage multiple projects in a fast-paced hybrid environment.
- Familiarity with device regulatory strategy for DHT clinical trials, standard submission processes, and regulatory documentation.
- Knowledge of clinical development, device/IVD development (design controls), manufacturing, and regulatory requirements; standards for software development lifecycle, labeling, documentation, risk management, clinical evaluations, and usability.
Benefits (as stated):
- Health and wellbeing benefits, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.