Analyst EHDS / Health Documentation Systems

Läkemedelsverket · Full-time

Dag Hammarskjölds väg 42, Uppsala, Sweden

Our Operations The medical device field is currently experiencing rapid and significant development. The Swedish Medical Products Agency's Medical Device Operations unit has the important mandate to ensure that products are safe and fit for purpose, and that they are available on the market. We are responsible for supervising medical device products and working to ensure that market actors have favorable conditions to comply with applicable regulations. We disseminate knowledge, promote innovation and develop regulations, provide support regarding product accessibility, and designate and oversee notified bodies. With technological advancement and increased digitalization, our mandate is expanding into additional areas such as cybersecurity, AI, information security, and health data management. We are now seeking staff for the Regulations and Regulatory Support unit with an interest in health documentation systems who want to work, among other things, with implementing the EHDS Regulation in Sweden based on the Swedish Medical Products Agency's role and responsibilities. Your Responsibilities In this role, you will be responsible for coordinating and driving work on efficient and harmonized implementation of EHDS in Sweden. You will contribute to ensuring clear internal processes and structured information sharing within the Swedish Medical Products Agency and to the agency's active participation in the European implementation of the regulations. The responsibilities include, among other things: coordinating the Swedish Medical Products Agency's internal work on EHDS, including planning, information sharing, and consultation processes preparing for, participating in, and following up on inter-agency collaboration within national, Nordic, and European forums related to EHDS, for example for market surveillance authorities and digital health authorities developing and maintaining the national collaboration framework between relevant authorities and stakeholders representing the Swedish Medical Products Agency in Nordic and European working groups, workshops, and other relevant forums preparing for and following up on the agency's participation in established consultation forums with relevant stakeholders monitoring external developments and identifying prioritized issues within EHDS, and analyzing when and how the Swedish Medical Products Agency needs to engage and contribute perspectives contributing to preparations for the Swedish Medical Products Agency's future role as a market surveillance authority (MSA) and to work establishing and operating test environments assisting with information and guidance regarding EHDS, health documentation systems, medical device software, etc., to industry and healthcare. The role involves an extensive network both internally and with other Swedish authorities, EU institutions, and external stakeholders. The work requires the ability to independently drive issues forward, create structure in complex contexts, and simultaneously build good relationships and effective collaboration. Your Background We are looking for someone who has: an academic degree with a technical, medical data, or natural science focus, or other experience or education relevant to the position work experience with healthcare software (such as electronic health records, health documentation systems, or national medical information systems) in areas such as development, administration, or similar. This may include work in industry, healthcare, government agencies, or similar strong ability to express yourself in both speech and writing in Swedish and English. It is a merit if you have: worked with and have knowledge of the European Health Data Space (EHDS) knowledge of medical device software worked with patient record systems and national medical information systems, for example in development or administration worked in the role of system architect or product owner worked with and have knowledge of the General Data Protection Regulation (GDPR) and the Patient Data Act with integration into healthcare patient record systems and national medical information systems worked with regulatory matters in medical devices, in vitro diagnostics, cybersecurity, or information security worked in the areas of system design, interoperability, integration, or usability regarding health data experience with policy or regulatory work in government agencies, particularly in a coordinating role with external stakeholders Your Personal Qualities You are proactive, organized, and have strong analytical and communication skills. You possess good collaboration abilities and can work independently as well. You work goal-oriented, set timelines, and have the ability to complete according to plan or can reprioritize in a justified manner. You are flexible and adapt easily to changing circumstances. You are good at switching perspective between broad issues and detailed levels. We place great importance on personal qualities. Good to Know Application Deadline: 2026-10-05 Employment Type: Permanent Start Date: By agreement Unit: Regulations and Regulatory Support File Number: 2.4.1-2026-073497 We apply a 6-month probationary period. We value diversity and welcome applicants with different backgrounds. At the Swedish Medical Products Agency, you have good conditions for work-life balance. We offer you, among other things, flexible working hours, favorable vacation terms, wellness allowance, and wellness activities during work time. To the extent that work tasks permit, there is the possibility to work partially remotely by agreement with your manager. Read more about the benefits you get from us here: https://www.lakemedelsverket.se/sv/om-lakemedelsverket/jobba-pa-lakemedelsverket/formaner-hos-oss The Swedish Medical Products Agency is a preparedness authority, which means we conduct certain background checks in connection with recruitment. At a potential interview, you will need to verify your identity and provide evidence of your degree and relevant certificates. All permanent staff at the Swedish Medical Products Agency are on civil contingency roster within the agency. Contact You are welcome to contact Unit Manager Emma Lundberg, [email protected]. You can also contact the union representatives Jonas Walldén, Saco, and Pia Wictor, ST. You can reach us by phone 018-17 46 00 or by email [email protected]. More About the Swedish Medical Products Agency Read more about our mandate and what it means to work at the Swedish Medical Products Agency here: https://www.lakemedelsverket.se/sv/om-lakemedelsverket/jobba-pa-lakemedelsverket We look forward to your application! This recruitment is conducted entirely by the Swedish Medical Products Agency. We therefore decline telephone calls from recruitment firms and advertising sales representatives.