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Regulatory Manager - Advertising and Promotion

  • Location

    Other Locations

  • Salary


  • Sector


  • Job Ref


  • Contact

    Alex Williams

  • Published

    26 days ago


Primary Function

Our client is looking for Subject Matter Expert for regulatory review and approval of all commercial and medical education materials. The Regulatory Manager will provide clear regulatory guidance on advertising and promotional activities to ensure compliance with FDA regulations/guidance and company procedures.


  • Regulatory review and approval of advertising and promotional materials, ensuring that materials are consistent with the device label and compliant with current regulations
  • Assess the regulatory risk and provide mitigation strategies for new marketing and medical education campaigns * Oversee and coordinate the Medical, Legal, Regulatory (MLR) review process working closely with legal and medical affairs to ensure claim substantiation and adequate risk communication
  • Responsible for selection and implementation of a promotional review software including developing and implementing procedures to support electronic reviews
  • Monitor and interpret enforcement letters, evaluate new guidance documents, and attend industry/FDA meetings to ensure current best practices
  • Work together with Regulatory Associate to manage FDA submission of promotional materials (FDA Form 2253)

Special Knowledge/Skill

  • Prior experience in a role responsible for the review and approval of advertising and promotional materials for medical devices, drugs, or biologics
  • Strong negotiation and communication skills
  • Ability to organize and prioritize workflow
  • Ability to interact with all levels of employees including senior management
  • Strong attention to detail


  • 5 - 10 years of medical device regulatory experience with ad/promo emphasis


* Bachelor's degree or higher