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Regulatory Affairs Manager

QA | Haifa

Responsibilities

  • Develop global regulatory strategies for Beyeonics products to meet business objectives and collaborate across the different teams to ensure products’ successful commercialization.
  • Being a member of product development teams, and providing regulatory inputs to the different teams through all stages of product development, distribution and servicing, to ensure compliance with procedures and regulatory requirements. Reviews and approves technical documentation.
  • Participate in Product Development teams, providing regulatory strategies, timelines, and direction. Reviews and approves technical documentation.
  • Development and timely submission of regulatory applications, license renewals, periodic updates, and registrations of defined products with different regulatory agencies.
  • Maintenance of global product regulatory documentation, approvals, and product renewals.
  • Understanding and monitoring frequently changing regulations in all the countries in which the company wishes to distribute its products.
  • Supporting internal and external regulatory audits and maintaining the company’s regulatory compliance status.

Requirements

  • A Bachelor’s degree in Biological Sciences, and/or Engineering.
  • 5+ years of global Regulatory Affairs experience, addressing pre/post-market medical device regulatory requirements of the FDA, EU notified bodies, Israel MoH, etc.
  • Experience interacting with FDA and/or other regulatory agencies such as Q-sub preparations and meetings, submission issue meetings, and other interactions.
  • Experience with medical device software standards and regulations

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