Senior Manager, GRA Device Associate – Medical Devices and Combination Products

Sanofi

GRA Device Associate collaborating on regulatory strategies for medical devices and combination products at Sanofi. Contributing to innovative regulatory solutions and liaising with global teams for successful outcomes.

Posted 7/3/2026full-timeMorristown • Massachusetts, New Jersey • 🇺🇸 United StatesSenior💰 $122,250 - $176,583 per yearWebsite

About the role

Key responsibilities & impact

Partner with the Device Regulatory Lead on assigned projects
Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional teams
Contribute to and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices and device part of combination products elements
Contribute to device Health Authority interactions plan, support device related and cross-functional health authority interactions
Identifies medical devices regulatory acceleration opportunities and regulatory risks, and proposes thoughtful risk mitigations in collaboration with the GRT
Identify issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed
Support 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 and review design control deliverables
Contribute to product development and lifecycle management planning
Provide regulatory impact assessments for proposed product changes
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.

Requirements

What you’ll need

Bachelor's degree in a scientific or engineering discipline
Advanced degree (Master or PhD) preferred
6+ years of relevant pharmaceutical OR biotechnology OR medical device industry experience
3+ years of regulatory experience (combination of CMC, device, and combination product) with contributions to regulatory filings and implementation of regulatory strategies
Experience responding to Health Authority questions
Familiarity with implementing device regulatory strategies to support product development, clinical use, and commercialization, including change controls
Familiarity with preparing regulatory documentation and standard submission processes
Understanding of drug clinical development, device development (including design controls), and working knowledge with technical/industry standards related to medical devices
Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Device, Manufacturing, and Quality teams
Strong written and verbal communication skills, with fluency in English.

Benefits

Comp & perks

high-quality healthcare
prevention and wellness programs
at least 14 weeks’ gender-neutral parental leave

ATS Keywords

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Hard Skills & Tools

Regulatory FilingDesign ControlChange ControlRegulatory Impact AssessmentSubmission Tracking

Soft Skills

Strong Communication SkillsCross-Functional CollaborationProblem-Solving