Pre-Market Regulatory Affairs Manager Job at Prestige Recruiting Firm, Clearwater, FL

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  • Prestige Recruiting Firm
  • Clearwater, FL

Job Description

Pre-Market Regulatory Affairs Manager
Remote


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

Job Tags

Remote job,

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