Back to Careers

Regulatory Affairs Manager

JOB #
20226
 / 
Neve Ilan, Israel

Job Description

Responsibilities

  • Support, prepare and coordinate regulatory submissions of multi disciplinary medical devices, including electromechanical parts, software and cloud.
  • Develop regulatory strategy for submissions of new products and changes to existing products in compliance with 21 CFR Part 820, MDR and other markets’ regulations.
  • 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 requirements.
  • Review 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 Medical Devices.
  • Experience in regulatory submissions of new products.
  • Excellent written and verbal communication skills, including proficiency in medical terminology from several disciplines.
  • Strong multitasking ability with impeccable attention to details.
  • Ability to work independently.

Send your CV to HR@nanox.vision