Regulatory Affairs Specialist

Abbott Diagnostics Technologies AS

Oslo, Norway
Ivd product registration
Global regulatory requirements
Iso, fda, ivdd/ivdr compliance
Contribute to the registration, maintenance, and compliance of in vitro diagnostic (IVD) products across international markets

Job Summary

  • Contribute to the registration, maintenance, and compliance of in vitro diagnostic (IVD) products across international markets.
  • Ensure all activities comply with Abbott procedures and global regulatory requirements (ISO, FDA, IVDD/IVDR).
  • Working at Abbott means joining a global healthcare company with excellent development opportunities, a supportive culture, and the chance to contribute to technologies that make a real difference.

Matching Summary

Contribute to the registration, maintenance, and compliance of in vitro diagnostic (IVD) products across international markets.

Skills & Requirements

Must-have

  • IVD product registration
  • global regulatory requirements
  • ISO, FDA, IVDD/IVDR compliance
  • technical documentation maintenance
  • UDI implementation and maintenance
  • fluent Norwegian and English

Nice-to-have

  • quality mindset
  • process improvement initiatives
  • collaborative team member
  • ethical behavior and accountability
  • open-minded and receptive to feedback

Key Requirements

  • Bachelor's degree in a relevant field
  • 2-3 years of experience in Regulatory Affairs
  • Experience supporting IVD or medical devices
  • Strong attention to detail
  • Ability to manage multiple tasks simultaneously

Work Rights

Not specified

Tailored Resume

Cover Letter