RA Senior Manager

Responsibilities:

  • Define Regulatory Requirements for defined company products
  • Provide related guidance of the Process and Design Controls (Design and Development Planning, Design Input and Output, Design Review, Verification & Validation, Design transfer, Design changes) regarding defined products to the R&D core teams
  • Development and timely submission of regulatory applications, license renewals, periodic updates and registrations of defined products with different regulatory agencies
  • Ensure regulatory compliance of defined products and processes
  • Disseminate regulatory information to different company departments (Operations, production, Quality assurance, R&D, Marketing, etc.) and senior management, as required
  • Develop department procedures and conduct applicable global training regarding same
  • Participate in research of arising regulatory issues

Skills and Experience:

  • Minimum of 8 years experience with managing regulatory projects and leading registrations of Medical Devices in EU/US/China/Canada markets (in all markets – working with Class II and/or III devices)
  • BSC. or B.A. degree in scientific or technical discipline. Advanced degree preferred
  • Independent professional
  • Leadership skills
  • English – Native level language skills (verbal & writing)
  • Excellent communication skills (verbally and in writing, both Hebrew and English)
  • Ability to multitask and manage multiple projects to meet deadlines
  • Ability to work with cross-functional global teams and across different cultures
  • Ability to write, review and compile complex documents/submission dossiers (English)
  • Management experience of a small team – preferred
  • RAPS RAC – advantage

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