Vacant job

We are now looking for an R&D Engineer for Nordic Biomarker with a focus on CE marking according to IVDR!

Do you want to help develop future solutions in coagulation diagnostics – from idea to finished product, while simultaneously contributing to ensuring our products meet the high requirements of the IVDR?

With the world as its market, Nordic Biomarker is a small giant in the life science industry, developing, manufacturing, and selling quality products for coagulation diagnostics under one roof. You are welcome to a workplace characterized by a family feel, good cooperation, colleague engagement, and pride in the societal benefit of our products.

The position is a permanent employment with possible location in Umeå or Linköping. We warmly welcome your application!

About the role

As a project manager in the Research and Development department, you are responsible for projects related to the CE marking according to IVDR of products within coagulation diagnostics. The projects may include CE marking of new reagents, updating existing products for CE marking according to IVDR (formerly IVDD), as well as product changes, such as customer-specific kits or new reagent and instrument combinations.

The projects involve work through the entire development and regulatory process, from planning and requirement setting to verification, documentation, and final CE marking. You play a central role in ensuring that products meet regulatory requirements and that necessary technical documentation is produced.

You are responsible for planning, coordinating, and driving the projects forward in close collaboration with other departments. The role also includes producing and compiling technical documentation, leading and documenting risk management according to current standards, and planning and coordinating activities related to analytical performance evaluation. If needs arise in the projects, there is an opportunity to participate in laboratory work. You also ensure that projects are delivered according to schedule and set goals.

Since the role involves close collaboration with other functions in the company, your communication skills and non-hierarchical working style are crucial. With many internal contacts, you have the opportunity to work together with experts in several areas such as Production, QA, and Marketing.

We are looking for you who

• Have a university degree in biochemistry, biotechnology, or equivalent
• Have experience in project management, preferably within product development or regulatory affairs
• Are structured, meticulous, and have the ability to drive work forward
• Are proactive and solution-oriented
• Have good teamwork skills and thrive working in cross-functional teams

In this recruitment, we place great emphasis on your personal qualities. Engagement and a genuine interest in the work are central traits that characterize you.

Meritorious

• Experience in in vitro diagnostics or a related field
• Experience working within quality management systems, preferably according to ISO 13485
• Experience with the EU regulation for in vitro diagnostics (IVDR)
• Experience working with regulatory requirements outside the EU, such as FDA

Salary range

At Nordic Biomarker, we use a recognized tool for job evaluation, salary mapping, and salary setting. Nordic Biomarker is covered by the collective agreement between IKEM, Unionen, Sveriges Ingenjörer/Naturvetarna, and Ledarna, which means that salary setting is individual and differentiated. This means, among other things, that the final salary is set with regard to the applicant's previous work experience and competence. For this position, the starting salary is between 37,000–47,000 SEK per month.

About us

Nordic Biomarker is a leading manufacturer and supplier of advanced reagents and control materials for coagulation analysis. The headquarters are located in Umeå, but research and development as well as manufacturing are conducted at the company's two sites, Umeå and Linköping. We offer both CE-marked kits under the brand Medirox and customized solutions for companies that want to use our products under their own brand.

Here, you will work in an environment where your work truly makes a difference – for our products, our customers, and ultimately the patients. We value curiosity, engagement, and a non-hierarchical working style where everyone contributes and supports each other regardless of the scope of the task.