Global IVD Regulatory Affairs Specialist – Lifecycle Ownership

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

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.