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

📋 Description

• Responsibility for products/multiple driver indications for a product within a Therapeutic Area and
• Leads total product lifecycle activities, including product/manufacturing change assessments
• Manages interface with Health Authority (FDA) for key projects/issues, including direct
• Advises internal customers who may contribute to regulated communication on Regulatory/FDA issues
• Operates independently, with recognition of when to consult management; makes decisions and plans
• Coordinates, prepares and/or supervises the preparation and review of regulatory submissions

🎯 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)
• Eligibility to participate in long-term incentive programs