Gentian AS is a company in growth, and our Quality Assurance and Regulatory Affairs department is looking for a new colleague to strengthen our team. The department is responsible for compliance towards regulations for our processes and products, as well as preparing and maintaining documentation for approval of our products in markets world-wide in cooperation with internal and external stakeholders. The Quality Assurance and Regulatory Affairs department has an important role with respect to complaints, continuous improvements and support the organisation in quality and regulatory topics.
As a Regulatory Affairs Officer your main responsibilities will be to prepare our Quality Management System and regulatory documentation for thein-vitroDiagnostic Regulation (IVDR), and support the organization’s readiness towards the upcoming IVDR transition (Regulation (EU) 2017/746 on in vitro diagnostic medical devices).
For this position, we are looking for you who has a positive spirit, is motivated by challenges, have the ability to work independent as well as in interdisciplinary teams.
Main work tasks
Prepare regulatory documents for Gentian's products according to thein-vitroDiagnostic Regulations and other regulations for the respective markets (i.e. US, China, Brazil, Canada)
Maintain regulatory documentation for Gentian’s IVD products throughout the lifecycle of the product according to thein-vitroDiagnostic Regulations and other regulations for the respective markets
Prepare the Quality Management System to meet requirements inin-vitroDiagnostic Regulations and other relevant regulatory requirements
Work with the Marketing department to provide input on regulatory strategy
Coordinate additional internal and external activities when required for regulatory applications
Work with product managers to follow up regulatory requests from national authorities and customers
Keeping yourself and the company updated on regulatory requirements
Support with tasks in Quality Assurance as needed such as Procedures, Non-Conformance's, Changes, Complaints, Internal and Suppliers audits etc.
Preferred qualifications and skills
Higher degree in science/technology (M.Sc or equivalent), relevant experience can compensate for education
Regulatory experience and/or experience from IVD, ISO 13485 or medical devices is an advantage
Good communication skills in English both oral and written
Good IT skills and use of standard MS Office tools
Systematic and accurate in your work
Hard working and flexible
Organised and patient
Motivated by common goals
What we can offer
A challenging and interesting position with opportunities for professional and personal growth.
A social, informal environment with highly skilled colleagues in a growing, high technology company within the Life Science sector.
Gentian AS develops and market high quality, in vitro diagnostic assays for the global clinical laboratory market, both human and veterinary. Gentian´s products have gained substantial market share due to their high quality from utilising our proprietary, innovative technology for nanoparticle enhanced diagnostic tests. Gentian performs production, R&D, marketing and distribution from our headquarters in Norway, Moss and our representative offices in China, Sweden and US. The company coordinates several well-funded international R&D projects partnered by leading clinical and commercial organisations using our nanoparticle-based technologies. Several exciting and original diagnostic products are in the pipeline, and new employment opportunities are being created. Today Gentian employs 40 persons of varied age, professional background and nationality.