SEROs control materials are used in medical laboratories to ensure the correct analytical performance, which means that patients all over the world can benefit from correct treatment based on trustworthy results. We are looking for a Regulatory Affairs Specialist to strengthen our team. As Regulatory Affairs Specialist, you will ensure our products, and our organisation, is living up to the demands put upon us by the global markets we operate in.
Your contribution will be critical for SERO’s success and you will work together with experienced academic colleagues in other departments.
The position reports to the Quality Manager and is located in Billingstad close to Oslo.
Main tasks and responsibilities
- Lead the process of registering our products in new markets, as well as maintaining existing product registrations.
- Support the definition and execution of our Regulatory Affairs strategy for IVD products.
- Build up knowledge and expertise of the standards and regulations in EU & key international markets.
- Join product development teams to provide crucial regulatory input during development projects.
- Support the continuous tasks to ensure our products are complying with relevant regulations.
- Support process and organisational development to align with standards and regulations.
- A degree in a relevant scientific field (Natural Sciences such as Biology, Medicine, Pharmacy, Physics, Chemistry; Engineering such as Biotechnology, Medical Technology), at Master or PhD level, or equivalent work experience.
- Excellent communication and writing skills in English and Norwegian (or Scandinavian language), minimum B2 level.
- Knowledge and understanding of Medical Device or in-vitro diagnostics industry is a strong benefit.
- Enthusiasm to learn about relevant standard and regulations and the ability to translate the general text to what is relevant for our organisation.
- Enjoy independent learning on the job. Take decisions and get things done with appropriate support.
- Enjoy working in cross functional teams.
- Fulltime position in an established biotechnology company with a positive development.
- An organisation with a flat hierarchy with short decision routes.
- Ability to define and make the position your own.
- Benefit package including attractive pension scheme.
Place of work is at our office in Billingstad, around 15 km south west of central Oslo. If you have any questions, please contact Jon Lind, Deputy Quality Manager, [email protected]
SERO AS is a family-owned company with a revenue around 130 MNOK, of which about 95% constitutes of export to over 50 countries. Our facilities are in Billingstad with around 60 employees in R&D, production, laboratory analysis, quality, regulatory, sales and marketing, IT and administration.