Regulatory Affairs Specialist
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 affairs 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.
- Plan, track and prepare global regulatory submissions for global markets for new product lines, mostly 510(k), CE class 1 & 2
- Define and execute regulatory strategy for new products and changes for existing products, including research and finding the perfect predicate device
- 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
- Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.
- Provides internal training on understanding, interpretation and implementation of standards and regulations.
- Works closely as key team member along with R&D, Quality, Regulatory, Clinical, Product management and Business on all aspects of product life cycle.
- Plans, reviews, tracks, executes, approves all forms of quality systems requirements such as CAPAs, change orders, regulatory assessments
- 6+ years of experience in similar position in the medical device industry, 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