Pre-Market Regulatory Affairs ManagerRemote

Why Join Us:

• Be part of an established leader in the aesthetics industry with exciting new innovations
• Help shape the regulatory path for groundbreaking beauty & wellness technologies
• Work in a collaborative, dynamic environment with growth opportunities
• Competitive salary, benefits, and a supportive company culture

About the Role:We’re seeking an experienced Pre-Market Regulatory Affairs Manager to drive global regulatory strategy and execution for our growing portfolio of innovative aesthetics products — including our latest breakthrough launch. You’ll collaborate across teams to ensure compliance with US and international regulations while bringing cutting-edge beauty and wellness solutions to market.

What You’ll Do:

• Lead preparation & submission of global regulatory filings (FDA, EU MDR, Health Canada, etc.)
• Advise product development teams on regulatory requirements and strategies
• Manage and maintain regulatory documentation, archives, and submission tracking
• Act as liaison with global regulatory agencies and during audits/inspections
• Ensure compliant product labeling, IFUs, UDI/GTIN registrations
• Stay current on evolving regulations in aesthetics/medical device markets
• Partner with Quality, Clinical, Marketing, Manufacturing, and Supply Chain teams
• Support new product launches and continuous process improvements
• Provide mentorship and leadership to regulatory specialists as needed

What You Bring:

• Bachelor’s degree in engineering or life sciences
• 6-12 years of regulatory affairs experience in medical devices; aesthetics or consumer wellness industry a plus
• Strong understanding of global regulatory frameworks (FDA, EU MDR, ISO 13485, QSR)
• Knowledge of software validation, electrical safety standards, and risk management
• Proven track record supporting new product launches and cross-functional collaboration
• RAC certification is a plus