Manager, Regulatory Affairs

South Bay, CA

Posted: 08/09/2018 Employment Type: Direct Hire Industry: Healthcare Job Number: JOS000007917

Essential Job Functions:

  • Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process.
  • Complete submissions to FDA, EU regulatory entities.
  • Create and maintain product EU technical files.
  • Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws.
  • Supervise Regulatory Affairs consultants as required.
  • Support External Audits.
  • Lead and manage CAPA related projects, as needed.
  • Facilitate Post-Market Surveillance reports.
  • Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance
  • Excellent interpersonal skills
  • A self-starter, motivated and able to positively motivate others
  • Focused, target driven with a positive, can-do attitude 

People Management:

  • Provide leadership, direction, management and development to project teams
  • Set department objectives/KPIs and review and assess ongoing performance of direct reports
  • Report on achievement of targets and identify any actions required
  • Motivate and coach the team to operational success 

Requirements/Qualifications:

    • Bachelor’s degree in Engineering or Science (or similar).
    • RAC certification or equivalent.
    • Minimum of 10+ years of hands-on experience with increasing Regulatory Affairs responsibilities.
    • Experience with External Audits (FDA and Notified Body) presenting topics/data related to Regulatory Affairs.
    • Prior experiences in the medical device space, preferably in working on Capital Equipment devices.
    • Ability to work effectively in a fast paced and dynamic environment.
    • Leadership and interpersonal skills to develop and manage good working relationships with internal departments (manufacturing, receiving, purchasing, product development, and regulatory), contractors, and suppliers; strong written and verbal communication skills.        

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