Do you want to work with medical technology products?

Do you want to work to ensure the safe and compliant use of medical technology products? With us, you will 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 meets applicable legislation in a structured and traceable manner, with a particular focus on medical technology products and NMI (National Medical Information Systems). Furthermore, you will work to ensure that regulatory requirements in medical technology are integrated and complied with in the authority's processes, methods, and management systems, contributing to a long-term and sustainable compliance effort.

As a specialist in the medical technology regulations, you will be part of a team of seven NMI specialists currently 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 regulations (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 unit for Quality and Regulatory Compliance maintains a soon-to-be-certified quality management system according to EN-ISO 13485.

About you

In recruitment, 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 in 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 with 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 development and compilation of technical documentation for medical technology products or equivalent regulations in connection with development
• very good ability to express yourself in Swedish, both orally and in writing.

It is an advantage for the position if you have:

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

What do we offer?

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

We are approximately 600 employees in Kalmar and Stockholm. With us, there is an 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 permanent with a six-month probationary period. 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 handled by the E-health Agency's HR unit, and we kindly decline sales calls from recruitment companies and advertisement sellers.