Governance, Risk, Compliance Manager
Fragomen
Global Regulatory Affairs Device Lead – Associate Director
Sanofi
full-time
Posted on:
Location Type: Hybrid
Location: Morristown • Massachusetts, New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $147,000 - $212,333 per year
Job Level
Senior
About the role
- Serve as GRA Device Lead on assigned project teams
- Provide regulatory guidance and advice to Global Regulatory Team and cross-functional teams
- Develop and execute innovative and sustainable medical device regulatory strategies
- 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 business partners to enable successful regulatory outcomes
- Prepare, review, and approve design control deliverables
- Ensure appropriate communication, resolution, and/or escalation of issues
Requirements
- 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience
- 5+ years of medical device and/or combination product regulatory experience
- Experience in large organizations
- Familiarity with international submissions from within a global healthcare organization
- Bachelor's degree in a scientific or engineering discipline; graduate degree preferred
- Strong written and verbal communication skills, fluent in English
- Ability to manage multiple projects in a fast-paced, hybrid work environment
Benefits
- Health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
- Remote work options
- At least 14 weeks gender-neutral parental leave
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategiesdevice submissionslifecycle managementdesign control deliverablesmedical device regulationscombination product regulationsinternational submissions
Soft skills
communication skillsproject managementproblem resolutioncross-functional collaboration
