Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device (Hybrid)
AbbVie124500 - 236500
Remotely
Listed on 2 job boards, which is a stronger signal than one board alone.
regulatory affairsmedical devicesdigital healthregulatory submissionsregulatory strategylifecycle managementall otherfda
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Job Description
📋 Description
- This role leads regulatory strategy and tactical planning for US & Canada for aesthetics
- Partner with Global Regulatory Product Team to ensure strategies are implemented and maintained
- Gather data to support regulatory filings, inquiries, and registration maintenance to enable
- Lead lifecycle activities, including change assessments, post-approval requirements, and Health
- Interface with Health Authorities (FDA) and coordinate meetings/briefing packages and responses.
- Advise internal customers on Regulatory/FDA issues across Regulatory, Legal, Clinical Development
🎯 Requirements
- Advanced degree (PharmD/PhD/MS) or Regulatory certification
- 5+ years in Regulatory/R&D or related industry experience
- Experience in the medical device space
- Experience with digital health/software
- Proven ability to implement affiliate regulatory strategies (US/Canada experience preferred)
- Experience in complex, matrix environments and interfacing with government regulatory agencies
🎁 Benefits
- Paid time off (vacation, holidays, sick)
- Medical/dental/vision insurance
- 401(k) plan
- Long-term incentive programs
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