The company has set out on a mission to help hundreds of millions of people receive access to fast, accurate medical diagnosis.
The Regulation team is responsible for the global registration and regulatory approvals of our products all around the world. We are looking for a regulatory affairs specialist to help us expand our growth in the global market.
This is a huge challenge and opportunity to 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.
Support the regulatory team in preparing, coordinating, tracking, and following up on approvals for medical device submissions including US 510(k), Health Canada licenses, EU technical files, Israel, Brazil, Australia and New Zealand and more
Research, plan, prepare, and obtain approvals for medical device submissions in growing global markets
Participate in regulatory inspections and audits
Prepare, review and approve product development documents, including test product requirements, risk analysis documents, clinical validation protocols etc.
Provides internal training on understanding, interpretation and implementation of global standards and regulations.
Works closely as key team member along with R&D, Quality, 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
Represent Regulatory Affairs on change controls and provide regulatory assessment.
Review and approve marketing communication materials
Act as liaison for communication with regulatory authorities or distributors regarding company’s regulatory filings.
Remain current on developments in field(s) of expertise, regulatory requirements and industry trends.
2+ years of experience in a RA/QA position in the medical device industry, with knowledge of US, European, and international medical device regulation
Preparing documentation for regulatory submissions (510(k), CE technical files)
Knowledge of statistical techniques in clinical validation studies- advantage
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
Able to produce positive results with a strong sense of urgency and ability to multitask.
Knowledge of Quality System Requirements and Standards.