Regulatory Affairs Specialist

Responsibilities
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. 
Review, approve and execute all forms of quality systems requirements such as CAPAs, change orders, regulatory assessments etc. 
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 the company’s regulatory filings. 
Remain current developments in field(s) of expertise, regulatory requirements, and industry trends. 
 
Requirements
2-3 years of experience in RA position in the medical device industry, with knowledge of US, European, and international medical
device regulation. 
Experience in preparing documentation for regulatory submissions (510(k), CE technical files). 
Knowledge of statistical techniques in clinical validation studies – an advantage. 
Experience with software medical device regulation – an advantage. 
Ability to perform well in a fast-paced startup environment. 
Self-driven, communicative, detail oriented, and excellent interpersonal skills and attitude. 
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