Regulatory Affairs Specialist

Job description

JOB DESCRIPTION: 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 dossiers - Prepare, update, and maintain technical document...