Making a global impact in Diagnostics

At Abbott Diagnostics Technologies AS, we develop technologies that deliver fast, reliable insights supporting better treatment decisions worldwide. Our Oslo site is home to the Afinion portfolio—rapid, reliable point‑of‑care diagnostics used globally to support patient care.

We are now looking for a Regulatory Affairs Specialist to support global regulatory activities for the Afinion line of products. If you’re passionate about quality, compliance, and helping bring impactful diagnostic solutions to market, this might be your next step.

Language requirements: Fluent Norwegian & professional English

What you’ll do

In this role, you will contribute to the registration, maintenance, and compliance of our in vitro diagnostic (IVD) products across international markets. Your main responsibilities will include:

Regulatory operations & compliance

Ensure all activities comply with Abbott procedures and global regulatory requirements (ISO, FDA, IVDD/IVDR)Perform registration activities for IVD products on a global scale, including collection and preparation of submission dossiersPrepare, update, and maintain technical documentation following IVDD/IVDR and internal processesReview product changes for regulatory impact and modification reportability

Documentation & systems

Provides support for updates to standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standardsManage and maintain data in regulatory databases and internal tracking systemsSupport UDI implementation and ongoing maintenance of UDI systems.

Cross‑functional support

Track regulatory milestones and provide regular status updates.Support internal stakeholders across Quality, Research & Development (R&D), Manufacturing, and other functions.Contribute to process improvement initiatives and special projects within Regulatory Affairs.

Quality mindset

Maintain strong awareness of how your work influences product quality and compliance.Act as a positive, professional representative of Regulatory Affairs across the organization.

What you bring

Bachelor’s degree in a relevant fieldMinimum 2-3 years of experience in Regulatory Affairs or a related functional area (Quality functions, Operations, R&D or similar) supporting IVD or medical devicesStrong attention to detail and the ability to manage multiple tasks simultaneouslyAbility to work independently while contributing positively to team collaborationClear, concise communication skills; able to adapt messages to different audiencesFluent in Norwegian (required) and business proficient in English

Who you are

Self‑driven, structured, and engagedSomeone who values ethical behavior, accountability, and transparencyOpen‑minded, receptive to feedback, and willing to challenge “the way we’ve always done it” to drive improvementsA collaborative team member who builds strong internal and external relationships

Why Abbott

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. You’ll be part of a team that values quality, innovation, and continuous improvement.