Gentian has an exciting opportunity as Regulatory Affairs Officer

Gentian has an exciting opportunity as Regulatory Affairs Officer to strengthen our team! We are implementing the new in-vitro Diagnostic Regulation (IVDR) and to meet the future requirements for our diagnostic products, we have a new position in our Quality Assurance and Regulatory Affairs department. As Regulatory Affairs Officer you will be responsible for maintaining the regulatory documentation for our IVD products throughout the lifecycle of the product, participate in multi-disciplinary projects to prepare for approval and launch of new products in the Gentian portfolio, provide regulatory support internally in the organization and towards customers and partners. The Quality Assurance and Regulatory Affairs department is a central function in Gentian, and this role will also support and be responsible for tasks within Quality Assurance and Clinical Affairs.

For this position, we are looking for you who 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 the in-vitro Diagnostic 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 products
• Support Director for Clinical Affairs with coordinating Clinical studies, study protocols and report
• Prepare and maintain the Quality Management System according to requirements in in-vitro Diagnostic Regulations (IVDR) and other relevant regulatory requirements
• Responsible for regulatory strategy for launch of new products in our IVD portfolio
• Support with tasks in Quality Assurance as needed such as Procedures, Non-Conformances, Changes, Complaints, Internal and Suppliers audits etc.

Preferred qualifications and skills

• Higher degree in science/technology/biology/chemistry or related field (M.Sc or equivalent)
• Regulatory experience and/or experience from IVD, ISO 13485 or medical devices is an advantage
• Good communication skills in English both oral and written
• Systematic, organized and accurate in your work
• Hard working and flexible
• 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.