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

📋 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