Regulatory Affairs Specialist

GENTIAN AS; Moss; On-site; NOK 700,000 - 900,000; Full time

Job summary

Gentian AS, headquartered in Moss, Norway, is a growing international diagnostics company developing and manufacturing innovative in vitro diagnostic products. The Regulatory Affairs Specialist will join the Quality & Regulatory team and take regulatory ownership for assigned products across the lifecycle.

The role involves shaping regulatory strategy, leading submissions, and collaborating with R&D, QA and operations to enable global market access and ongoing product development.

Qualifications

• Regulatory affairs experience in IVD/regulated life sciences.
• Ability to plan and execute regulatory submissions and maintain documentation.
• Interpret regulations and translate them into practical actions.

Responsibilities

• Own regulatory activities for assigned products and projects.
• Plan and lead regulatory submissions and registrations in international markets.
• Prepare and maintain technical documentation in compliance with applicable regulations.
• Provide regulatory guidance throughout product development and commercialization projects.
• Monitor and interpret regulatory developments and assess their impact on Gentian’s products and business.
• Support and, where appropriate, lead interactions with Notified Bodies and regulatory authorities.

Skills

Regulatory submissions

Regulatory strategy

Cross-functional collaboration

English communication

Life sciences knowledge

Education

Degree in Life Sciences, Biotechnology, Pharmacy, Chemistry or related field

Job description

• Sektor Privat

Manage regulatory activities, submissions, and technical documentation for IVD products across the lifecycle.

• Degree in Life Sciences, Biotechnology, Pharmacy, Chemistry or a related field
• Several years of Regulatory Affairs experience, preferably from IVD, medical devices or regulated life science
• Experience with regulatory submissions, technical documentation or product development projects
• Strong communication skills in English
• Opportunity to influence product development from an early stage
• Work with global regulatory pathways and market access activities
• Collaborate closely with experienced colleagues across Regulatory Affairs, Quality and R&D
• Take increasing responsibility as the company and product portfolio grow

Help bring innovative diagnostic solutions to patients worldwide?

Gentian is a growing international diagnostics company developing and manufacturing innovative in vitro diagnostic (IVD) products.

To support our expanding product portfolio and international ambitions, we are strengthening our Regulatory Affairs capabilities and are looking for an experienced Regulatory Affairs Specialist to join our Quality & Regulatory team at our headquarters in Moss, Norway.

This is an opportunity to take regulatory ownership for assigned products and projects and work across the entire IVD product lifecycle – from development and regulatory strategy to market access and post-market activities.

You will work closely with colleagues across R&D, Quality Assurance, Marketing and Operations and play an active role in translating regulatory requirements into practical solutions that support product development and international growth.

Key responsibilities

You will:

• Own regulatory activities for assigned products and projects.
• Contribute to regulatory strategies for new products, product changes and market expansion.
• Plan and lead regulatory submissions and registrations in international markets.
• Prepare and maintain technical documentation in compliance with applicable regulations.
• Provide regulatory guidance throughout product development and commercialization projects.
• Monitor and interpret regulatory developments and assess their impact on Gentian’s products and business.
• Support and, where appropriate, lead interactions with Notified Bodies, regulatory authorities, distributors and international partners.

Who we are looking for

We believe you have:

• A degree in Life Sciences, Biotechnology, Pharmacy, Chemistry or a related field.
• Several years of Regulatory Affairs experience, preferably from IVD, medical devices or another regulated life science industry.
• Experience with regulatory submissions, technical documentation or product development projects.
• The ability to interpret regulations and translate them into practical actions.
• You bring both regulatory expertise and a pragmatic, collaborative mindset.
• Strong communication skills in English and the ability to work effectively across functions.

At Gentian, Regulatory Affairs is closely connected to product development, quality, commercial priorities and business growth. As part of a growing IVD company, you will have broad visibility across regulatory disciplines and the opportunity to make a direct impact on products with international reach.

You will have the opportunity to:

• Influence product development from an early stage.
• Work with global regulatory pathways and market access activities.
• Collaborate closely with experienced colleagues across Regulatory Affairs, Quality and R&D.
• Take increasing responsibility as our company and product portfolio continue to grow.
• Contribute directly to bringing innovative diagnostic solutions to healthcare professionals and patients worldwide.

Interested?

If you have any questions about the role or the company, please contact Anne-Mette Akre, VP QA/RA at 416 17 027 or Bård Nordby, HR Manager at 922 87 160.

We look forward to hearing from you!

Gentian is a growing international diagnostics company developing and manufacturing innovative in vitro diagnostic (IVD) products. The diagnostic tests are sold globally, through direct sales and partnerships with world-leading diagnostic companies. The end users are clinical laboratories that utilize Gentian's tests to enable better treatment decisions and save costs. Gentian currently has 6 diagnostic tests sold worldwide, helping to save costs and protect lives.

Gentian AS is an international company with headquarters in Moss and offices all over the world. Gentian currently has approximately 65 employees with different national and professional backgrounds.

AA

Anne-Mette Akre

VP QA/RA

41 61 70 27

BN

Bård Nordby

HR Manager

92 28 71 60