Investigator in In Vitro Diagnostics

At the Medical Products Agency, we work for the health of people and animals, for a better Sweden today and in the future. Welcome to make a difference with us! Do you want to contribute to the safer use of medical devices in healthcare? We continue to grow in the field of medical technology and now want to expand our expertise in in vitro diagnostics (IVD).

Our Operations

The Medical Products Agency is tasked with ensuring that medical devices in Sweden are safe, effective, and suitable for their intended purpose. The agency has operated for several years within a unit for medical technology and currently consists of nearly 80 people. There is significant and rapid development in this area. To meet the increasing expectations on the agency, the 'Medical Technology Operations Area' will be established on January 1st, consisting of three units and a staff. This operational area covers the agency's responsibility to conduct supervision, support access to products, disseminate knowledge, and develop regulations.

We are now looking for an investigator with an interest in regulatory issues, focusing on in vitro diagnostics/laboratory medicine. The position belongs to the 'Unit for Regulations and Regulatory Support,' which currently consists of about 16 people. The unit primarily focuses on questions related to regulations for medical devices and medical devices for in vitro diagnostics.

Your Responsibilities

You will primarily work with regulatory issues within the medical technology field, with a particular focus on in vitro diagnostic products (IVD products). The work will be both individual and team-based, where you will also have direct contact with stakeholders in the field, such as manufacturers and healthcare providers. You will also communicate with sponsors of clinical trials and performance studies during the review and assessment of applications for such. The position also includes participating in collaborations with other authorities in Sweden and within the EU.

Your tasks include:

• assessing applications for clinical trials/performance studies (in vitro diagnostics) together with colleagues.
• informing about regulations, for example, by answering questions from manufacturers, healthcare, and other stakeholders handling products.
• contributing to the European collaboration on the development of regulations and the creation of guidance.
• contributing your expertise in market surveillance and, for example, during the review of referrals from other authorities.

Your Background

We are looking for someone with a university degree in a technical, medical, or natural science field and a few years of relevant work experience in medical devices and/or medical devices for in vitro diagnostics/laboratory medicine. Your experience may come from, for example, research, development, quality, regulatory issues, or the use of medical technology or in vitro diagnostics. You have good computer skills and can express yourself easily in both spoken and written Swedish and English.

It is an advantage if you also have:

• knowledge and experience from research and development of products within in vitro diagnostics.
• knowledge and experience from regulatory work or quality management within medical technology or in vitro diagnostics.
• experience of working with government agencies.
• a PhD in a field relevant to the position.

Your Personal Qualities

You are proactive, structured, and possess good analytical and communication skills. You have a good ability to collaborate but can also work independently. You work goal-oriented, set timelines, and have the ability to complete tasks as planned or can reprioritize in a justified manner. You are flexible and can easily adapt to changing circumstances. We place great emphasis on personal suitability.

Good to Know

Application deadline: 2026-01-12
Employment type: Permanent
Start date: By agreement
Unit: Unit for Regulations and Regulatory Support
Diary number: 2.4.1-2025-104502

We apply a 6-month probationary period.
We value diversity and welcome applicants from different backgrounds.

At the Medical Products Agency, you will have good conditions for work-life balance. We offer you, among other things, flexible working hours, favorable vacation conditions, wellness grants, and wellness during working hours. To the extent that work tasks allow, there is the possibility to work partially remotely by agreement with the manager.

Read more about the benefits you receive with us here: Benefits with us (https://www.lakemedelsverket.se/sv/om-lakemedelsverket/jobba-pa-lakemedelsverket/formaner-hos-oss)

The Medical Products Agency is a preparedness authority, which means that we conduct certain background checks in connection with recruitments. You will need to verify your identity and present your diploma and relevant certificates during a possible interview. All permanently employed staff at the Medical Products Agency are placed in wartime within the agency.

Contact

You are welcome to contact group manager Ola Philipson. You can also contact the union representatives Jonas Walldén, Saco, and Pia Wictor, ST. We are all available by phone at 018-17 46 00 or can be reached via email [email protected].

More about the Medical Products Agency

You may not think about the Medical Products Agency very often, but we can promise that you encounter us in your daily life. The results of what we do are visible at pharmacies, hospitals, with veterinarians, and in your bathroom cabinet. We ensure that you and everyone else in Sweden have access to safe and effective medicines and medical devices, from band-aids and pregnancy tests to walkers and apps. We do this by approving and granting permits, monitoring and controlling, and by informing and advising. We who work at the Medical Products Agency are proud of our important societal mission: to contribute to the health of the Swedish population and animals.

Read more about our mission and what it means to work at the Medical Products Agency here: Work at the Medical Products Agency (https://www.lakemedelsverket.se/sv/om-lakemedelsverket/jobba-pa-lakemedelsverket)

Welcome with your application! This recruitment is conducted entirely by the Medical Products Agency. We therefore ask for no phone calls from recruitment companies and advertisement sellers.