JOB TITLE: Regulatory Affairs Specialist

JOB DESCRIPTION:

What you will be doing:

  • Ensure regulatory compliance of defined products and processes
  • Development and timely submission of regulatory applications, license renewals, periodic updates and registrations of defined products with different regulatory agencies
  • Provide regulatory inputs to various Insightec teams (e.g. R&D, Operations, Quality, Marketing) both locally and around the world, along all stages of product lifecycle (pre and post market), to ensure compliance with procedures and regulatory requirements
  • Actively participate in regulatory impact evaluation of changes to Insightec’s products and processes
  • Provide technical review of data/reports that will be incorporated into regulatory submissions, to assure scientific rigor, accuracy, and clarity
  • Provide support for external/internal audits at HQ and globally, as needed
  • Help develop internal Regulatory Affairs related processes and knowledge share databases
  • Review of customer complaints to determine regulatory reportability requirements and execution of global adverse events reporting; analyze adverse events reporting data and investigations, as required
  • Participate in research of arising regulatory issues
  • Attend other regulatory related needs, as required

What you have:

  • BSc. in Scientific / Engineering/ Paramedical/Public Health/Pharmacy
  • 2+ years of global Regulatory Affairs experience, addressing pre/post market medical device regulatory requirements of the US FDA (Class III and/or Class II medical devices), EU notified bodies, Asian regulatory authorities, Israel MoH, etc.
  • Strong ability of text analysis and independent writing
  • Ability to assess and interpret regulatory requirements and their impact
  • Demonstrate sound scientific and technical knowledge
  • Ability to work with cross-functional global teams
  • Strong verbal and written communication skills (Hebrew and English)
  • Ability to multitask manage multiple projects to meet deadlines

Advantages:

  • Advanced degree
  • RAPS RAC
  • Being introduced by an Insightec employee

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