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Contract

Regulatory Manager - Advertising and Promotion

  • Location

    Other Locations

  • Salary

    Negotiable

  • Sector

    Compliance

  • Job Ref

    27174

  • Contact

    Alex Williams

  • Published

    26 days ago

Overview

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.

Duties/Responsibilities

  • 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

Experience

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

Education/Training

* Bachelor's degree or higher

Austin Vita is acting as an Employment Agency in relation to this vacancy.

Austin Vita is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.