Do you want to take part in improving a market leading Norwegian biotechnology company?

SERO is a pioneer in the field of quality control materials for in-vitro diagnostics. Our products are used in medical laboratories all over the world to ensure that patients can benefit from correct treatment based on trustworthy results.

We are looking for a Quality & Regulatory Affairs Specialist to strengthen our team. In the role, you will ensure our products, and our organisation, are 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 Head of Quality & Regulatory Affairs.

Main tasks and responsibilities

·      Manage, maintain, and improve our quality management system (QMS).

·      Support all functions around the company to understand and follow the QMS.

·      Take a key role in our internal audit program. Support external audits with competent authorities, notified bodies or customers.

·      Build expertise in standards and regulations relevant to SERO’s products and markets; ensure that SERO stays compliant with the same.

·      Take part in the internationalisation and globalisation of SERO by supporting market access initiatives around the world.

Experience

·      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).

·      Knowledge and understanding of Medical Device or in-vitro diagnostics industry is a strong benefit.

Personal characteristics

·      Willingness to take ownership of tasks, take decisions and get things done, with appropriate support considering your level of experience.

·      Enthusiasm to learn about relevant standards and regulations and the ability to translate the general text to what is relevant for our organisation. Being able to apply the knowledge to streamline our systems while staying compliant.

·      Enjoy working in cross functional teams.

Our offer

·      Full-time position in an established biotechnology company with a positive development.

·      An organisation with a flat hierarchy with short decision routes.

·      Opportunity to define and adapt the position to your own strengths and interests.

·      Benefit package including attractive pension scheme.

Place of work is at our office in Billingstad, around 15 km south west of central Oslo.

We encourage applications in either English or in Norwegian.