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Regulatory Affairs Specialist

Company: Katalyst Healthcares & Life Sciences
Location: Jersey City
Posted on: January 21, 2023

Job Description:

Responsibilities


  • Provide guidance in preparing country specific dossiers for submissions worldwide.
  • Generate templates for domestic (US FDA, Canada) and international (EU, Australia, Turkey, etc) submissions.
  • Communicate directly with the international affiliates and the regulatory intelligence team.
  • Update and maintain the submission templates.
  • Liaison the requirements with the Product Manager and the development team.
  • Manage the internal regulatory intelligence team.
  • Create internal processes and systems to ensure regulatory intelligence provided by RegDesk is of the highest quality.
  • Review work of regulatory intelligence team.
  • Contribute ideas to enhance RegDesk's RIM platform.

    Requirements:


    • Bachelor's Degree or equivalent experience preferred
    • Minimum 5 years' experience in the Medical Device Regulatory Affairs
    • Thorough understanding of US, EU, Canada regulations on medical devices and IVDs
    • Prior experience authoring dossier content and addressing health agency inquiries is a must
    • Superior attention to detail
    • Strong written and verbal communication skills
    • Able to multitask effectively and work independently with international oversight
    • Knowledge of 21 CFR Part 11 requirements

Keywords: Katalyst Healthcares & Life Sciences, Jersey City , Regulatory Affairs Specialist, Other , Jersey City, New Jersey

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