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Manager, Regulatory Affairs - Advertising & Promotion (Device)

Company: Bausch Health
Location: Irvine
Posted on: August 16, 2019

Job Description:

Bausch Health is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization's potential and what we hope it will become. The Manager / Senior Manager of Advertising & Promotion, Medical Device Product reviews, approves and monitors product advertising and promotional labeling pieces for compliance with regulatory agencies requirements.

  • Provides regulatory guidance regarding advertising and promotional materials, new campaigns and launch strategy.
  • Implements regulatory strategies and solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies
  • Monitors CDRH and FTC activity (as appropriate) including enforcement actions, guidance documents, etc. to analyze impact on company products and communicates risk to PRC(s)
  • Assures timely and accurate review of advertising and promotional material to meet internal guidelines and requirements
  • Monitors competitor advertising to keep abreast of market promotional and advertising strategies
  • Continually assesses the advertising and promotion related process to enhance efficiencies and compliance
  • Works closely with the Regulatory Affairs medical device product labeling group in order to assess and determine the disposition of proposed labeling changes
  • Other job responsibilities as needed
    • Bachelor degree in science or health related discipline (Advance degree PhD, MD, MS, PharmD preferred)
    • Eight to ten years of relevant experience with four plus years of relevant medical device product advertising and promotion experience.
    • Knowledge of the pharmaceutical / medical device industry regulator affairs
    • Demonstrated ability to contribute to a continuous learning and process improvement environment
    • Detail oriented with the ability to proofread and check documents for accuracy as well as consistency
    • Ability to work in a team environment
    • Working knowledge of medical device development, PMA, 510(k) submissions and strategies and post approval /lifecycle regulatory processes
    • Excellent communication skills; both oral and written
    • Strong interpersonal skills with the ability to influence others in a positive and effective manner Bausch Health is an EEO/AA employer M/F/D/V. Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms. To learn more please read Bausch Health's Job Offer Fraud Statement.

Keywords: Bausch Health, Irvine , Manager, Regulatory Affairs - Advertising & Promotion (Device), Executive , Irvine, California

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