Nanox is looking for a talented, team-oriented Regulatory Affairs Engineer\Specialist to support our Product Marketing and Regulations activities
Responsibilities
Develop regulatory strategy for submissions of new products and changes to existing products
Support, prepare and coordinate regulatory submissions of new products or changes to existing products
Prepare and maintain technical files and general safety and performance requirements
Coordinate and communicate activities with external consultants and regulatory bodies
Review DHF documentation to assure compliance with regulatory requirementsReview and interpret regulatory requirements during product development and communicate to the project team
Review of V&V protocols and reports to assure comprehensiveness, accuracy and clarity for regulatory submissions
Support Risk Management activities
Create, update and maintain standards list
Support manufacturing activities
Provide requirements for, review and approve product labelling
Support compliant handling
Requirements
B.S. degree in Life Sciences or equivalent
3+ years of experience in regulatory submissions of new products to regulatory agencies
Excellent written and verbal communication skills, including proficiency in medical terminology from several disciplines
Strong multitasking ability with impeccable attention to details
