Regulatory Affairs Engineer/Specialist

JOB #

9855

Job Description

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

Send your CV to HR@nanox.vision