Regulatory Affairs Specialist

Abbott Diagnostics Technologies AS

Oslo, Norway
Ivd product registration
Global regulatory requirements
Technical documentation
Support global regulatory activities for the Afinion line of products, contributing to the registration, maintenance, and compliance of in vitro diagnostic (IVD) products across international markets

Job Summary

  • Support global regulatory activities for the Afinion line of products, contributing 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) and prepare, update, and maintain technical documentation following IVDD/IVDR and internal processes.
  • 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

Support global regulatory activities for the Afinion line of products, contributing 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
  • technical documentation
  • regulatory databases
  • UDI implementation

Nice-to-have

  • ethical behavior
  • accountability
  • transparency
  • open-minded
  • collaborative team member

Key Requirements

  • Bachelor’s degree in a relevant field
  • 2-3 years of experience in Regulatory Affairs
  • Fluent Norwegian
  • Business proficient English

Work Rights

Not specified

Tailored Resume

Cover Letter