Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device (Hybrid)

Added
26 days ago
Type
Full time
Salary
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Related skills

regulatory affairs digital health pharmaceuticals fda medical device

📋 Description

  • Responsible for the development and implementation of US and Canada regulatory strategic and
  • Combine knowledge of scientific, regulatory & business issues to enable development and
  • Ensure regulatory strategies defined within the Global Regulatory Product Team (GRPT) are
  • Identify and gather data needed to support filings, responses to inquiries, and registration
  • Support the Global Regulatory Lead (GRL) in the development & execution of the regulatory
  • Lead total product lifecycle activities including product/manufacturing change assessments

🎯 Requirements

  • Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification
  • 5+ years Regulatory, R&D, or equivalent industry-related experience
  • Experience in medical device space
  • Experience with digital health/software
  • Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience
  • Experience working in a complex and matrix environment

🎁 Benefits

  • Paid time off (vacation, holidays, sick)
  • Medical/dental/vision insurance
  • 401(k)
  • Long-term incentive programs
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