Regulatory Affairs Specialist

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 portfoliorapid reliable pointofcare 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 youre 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 youll 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.

Crossfunctional 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

• Bachelors 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

• Selfdriven structured and engaged
• Someone who values ethical behavior accountability and transparency
• Openminded receptive to feedback and willing to challenge the way weve 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. Youll be part of a team that values quality innovation and continuous improvement.

The base pay for this position is

In specific locations the pay range may vary from the range posted.

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