Regulatory Affairs Specialist

Descripción del puesto:

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 documentation following IVDD/IVDR and internal processes
* Review 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 standards
* Manage and maintain data in regulatory databases and internal tracking systems
* Support 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 field
* Minimum 2-3 years of experience in Regulatory Affairs or a related functional area (Quality functions, Operations, R&D or similar) supporting IVD or medical devices
* Strong attention to detail and the ability to manage multiple tasks simultaneously
* Ability to work independently while contributing positively to team collaboration
* Clear, concise communication skills; able to adapt messages to different audiences
* Fluent in Norwegian (required) and business proficient in English

Who you are
* Self-driven, structured, and engaged
* Someone who values ethical behavior, accountability, and transparency
* Open-minded, receptive to feedback, and willing to challenge "the way we've always done it" to drive improvements
* A 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.

The base pay for this position is N/A
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Regulatory Operations

DIVISION:
CMI ARDx Cardiometabolic and Informatics

LOCATION:
Norway > Oslo : Kjelsasveien 161

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Not specified

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Not Applicable