Regulatory Specialist

Israel

About The Position

Zebra has set out on a mission to help hundreds of millions of people receive access to fast, accurate medical diagnosis, by teaching computers to read and diagnose medical imaging data.

The Zebra Regulation team is responsible for the global registration and regulatory approvals of Zebra’s products.

We are looking for a regulatory specialist to help us obtain regulatory approvals for the Zebra’s products across the world. 

This is a huge challenge and an opportunity to get in at a very interesting phase of the product, and make a significant impact - while working as part of a professional team in an environment which fosters innovation, independence, responsibility and keeps the customer in mind at all times.

Responsibilities

  • Prepare and maintain regulatory submissions, including 510(k), Technical Files, Letter-to-File and International Registration documentation
  • Define and execute regulatory strategy for new products and changes for existing products
  • Prepare, review and approve product development documents, including test protocols and reports, risk analysis documents, clinical validation protocols etc.
  • Participate in regulatory inspections and audits

Requirements

  • 4+ years in the medical device industry
  • Proven experience with preparing documentation for regulatory submissions (510(k), CE technical files)
  • Knowledge of statistical techniques in clinical validation studies
  • Experience with software medical device regulation - an advantage
  • Ability to perform well in a fast paced startup environment
  • Self driven, communicative, and fun to work with!

Skills

  • Excellent written and verbal communication skills: Hebrew and English

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