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.
- 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
- 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!
- Excellent written and verbal communication skills: Hebrew and English