Do you want to work to ensure the safe and compliant use of medical devices?

With us, you have the opportunity to combine regulatory expertise with the development of processes and methods in an organization with high quality and safety requirements.

About the position

In this role, you will ensure the authority's regulatory compliance in medical technology, in accordance with EU Regulation 2017/745 on medical devices (MDR) and applicable national requirements according to NMI. You will work on developing and managing specifications that create conditions for demonstrating that the organization complies with applicable legislation in a structured and traceable manner, with a particular focus on medical devices and NMI (National Medical Information Systems). Furthermore, you will work to integrate and comply with regulatory requirements within medical technology in the authority's processes, methods, and management systems, contributing to long-term and sustainable compliance work.

As a specialist in the medical technology regulatory framework, you will be part of a team of currently seven NMI specialists working with regulatory issues within the authority. The unit also includes a quality manager, quality coordinator, project manager, and a quality and environmental coordinator who work with the management system and processes that govern how the E-health Agency operates. As a specialist in the medical technology regulatory framework (NMI specialist), you are a central part of the work to develop patient-safe products and services.

In your daily work, you will closely collaborate with the authority's product managers and various development teams in the creation of patient-safe products.

The Quality and Regulatory Compliance Unit maintains a soon-to-be-certified quality management system according to EN-ISO 13485.

About you

In the recruitment process, we place great importance on your personal qualities, as they are crucial for how you will thrive and succeed in the role. Therefore, we are looking for someone who is proactive and works independently, even on complex and long-term issues. You are persistent and have the ability to maintain focus and quality over time while working in a structured manner. You are quality-conscious with an eye for detail and regulations, and you have good collaboration skills and enjoy working with others.

We are looking for someone who has:

• relevant academic education or equivalent work experience deemed comparable by the employer
• at least 3 years of current experience in regulatory issues related to MDR 2017/745 or NMI regulations HSLF-FS 2022:42
• current experience in quality management in operations that develop or handle products
• current experience in the preparation and compilation of technical documentation for medical devices or equivalent regulations in connection with development
• very good ability to express yourself in Swedish, both spoken and written.

It is advantageous for the position if you have:

• current experience working with tasks included in the role of PRRC for medical devices or the National Medical Information System
• current experience working in public sector
• current experience in maintaining and further developing products or medical devices.
• current experience in agile work

What do we offer?

The E-health Agency is a growing authority, and we are driving the development of national digital infrastructure within health, care, and welfare. We create conditions for digital services and solutions for both individuals and professionals within healthcare, pharmacies, and social services. We work to make health data accessible throughout the care chain.

We have about 600 employees in Kalmar and Stockholm. With us, you have the opportunity to make a difference in an innovative environment with friendly and competent colleagues. All employees have trust-based working hours and can work partially remotely. Read more about the E-health Agency as a workplace: Work with us (https://www.ehalsomyndigheten.se)

Are you interested?

Questions regarding the position can be answered by:

Unit Manager Magnus Adolfsson: [email protected] (mailto:[email protected])

Questions regarding the recruitment process can be answered by:

HR Specialist Gabriela Plachecka: [email protected] (mailto:[email protected])

Welcome to submit your application and CV via our recruitment tool by February 4, 2026. Please upload diplomas, grades, and certificates relevant to the position along with your application.

The selection questions are based on the requirements profile for this recruitment, and your answers will form the basis for the selection process. Answering the selection questions is a prerequisite for your application to be considered complete.

The employment is a temporary position for about 12 months. Start date as soon as possible or by agreement. The place of employment is Kalmar or Stockholm. The work may involve business trips, primarily between these two locations.

Employment with us may involve placement in a security class. Therefore, we may need to conduct a security review with a background check according to the Security Protection Act (2018:585). For some tasks in the security class, Swedish citizenship is required.

If you have a decision regarding protected personal information, please contact the HR specialist named in the advertisement.

Read more about us at www.ehalsomyndigheten.se (https://www.ehalsomyndigheten.se)

The recruitment is managed by the E-health Agency's HR unit, and we kindly decline sales calls from recruitment companies and ad sellers.