{"data":{"id":207466,"slug":"utredare-ehds-halsodokumentationssystem","type":"job","title":"Analyst EHDS \/ Health Documentation Systems","description":"Our Operations\nThe 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.\nWe 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.\nYour Responsibilities\nIn 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.\nThe responsibilities include, among other things:\ncoordinating the Swedish Medical Products Agency's internal work on EHDS, including planning, information sharing, and consultation processes\npreparing 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\ndeveloping and maintaining the national collaboration framework between relevant authorities and stakeholders\nrepresenting the Swedish Medical Products Agency in Nordic and European working groups, workshops, and other relevant forums\npreparing for and following up on the agency's participation in established consultation forums with relevant stakeholders\nmonitoring external developments and identifying prioritized issues within EHDS, and analyzing when and how the Swedish Medical Products Agency needs to engage and contribute perspectives\ncontributing 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\nassisting with information and guidance regarding EHDS, health documentation systems, medical device software, etc., to industry and healthcare.\n\nThe 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.\nYour Background\nWe are looking for someone who has:\nan academic degree with a technical, medical data, or natural science focus, or other experience or education relevant to the position\nwork 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\nstrong ability to express yourself in both speech and writing in Swedish and English.\n\nIt is a merit if you have:\nworked with and have knowledge of the European Health Data Space (EHDS)\nknowledge of medical device software\nworked with patient record systems and national medical information systems, for example in development or administration\nworked in the role of system architect or product owner\nworked 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\nworked with regulatory matters in medical devices, in vitro diagnostics, cybersecurity, or information security\nworked in the areas of system design, interoperability, integration, or usability regarding health data\nexperience with policy or regulatory work in government agencies, particularly in a coordinating role with external stakeholders\n\nYour Personal Qualities\nYou 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.\nGood to Know\nApplication Deadline: 2026-10-05\n \nEmployment Type: Permanent\n \nStart Date: By agreement\n \nUnit: Regulations and Regulatory Support\n \nFile Number: 2.4.1-2026-073497\n \nWe apply a 6-month probationary period.\nWe value diversity and welcome applicants with different backgrounds.\nAt 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.\nRead more about the benefits you get from us here: https:\/\/www.lakemedelsverket.se\/sv\/om-lakemedelsverket\/jobba-pa-lakemedelsverket\/formaner-hos-oss\nThe 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.\nContact\nYou are welcome to contact Unit Manager Emma Lundberg, emma.m.lundberg@lakemedelsverket.se. You can also contact the union representatives Jonas Walld\u00e9n, Saco, and Pia Wictor, ST. You can reach us by phone 018-17 46 00 or by email firstname.lastname@lakemedelsverket.se.\nMore About the Swedish Medical Products Agency\nRead 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\nWe look forward to your application!\nThis recruitment is conducted entirely by the Swedish Medical Products Agency. We therefore decline telephone calls from recruitment firms and advertising sales representatives.","language":"sv","is_translated":true,"title_original":"Utredare EHDS \/ h\u00e4lsodokumentationssystem","description_original":"V\u00e5r verksamhet\nInom det medicintekniska omr\u00e5det sker just nu en stor och mycket snabb utveckling. L\u00e4kemedelsverkets Verksamhetsomr\u00e5de Medicinteknik har det viktiga uppdraget att s\u00e4kerst\u00e4lla att produkter \u00e4r s\u00e4kra och l\u00e4mpliga f\u00f6r sitt \u00e4ndam\u00e5l samt att de finns tillg\u00e4ngliga p\u00e5 marknaden. Vi har till ansvar att ut\u00f6va tillsyn av medicintekniska produkter och verka f\u00f6r att akt\u00f6rer p\u00e5 marknaden har goda f\u00f6ruts\u00e4ttningar att f\u00f6lja g\u00e4llande regelverk. Vi sprider kunskap, fr\u00e4mjar innovation och utvecklar regelverk, ger st\u00f6d n\u00e4r det g\u00e4ller tillg\u00e5ng till produkter samt utser och \u00f6vervakar anm\u00e4lda organ. I takt med den tekniska utvecklingen och \u00f6kad digitalisering p\u00e5g\u00e5r en utvidgning av uppdraget inom ytterligare omr\u00e5den som exempelvis cybers\u00e4kerhet, AI, informationss\u00e4kerhet och hantering av h\u00e4lsodata.\u00a0\nVi s\u00f6ker nu medarbetare till enheten f\u00f6r Regelverk och Regulatoriskt st\u00f6d med intresse av h\u00e4lsodokumentationssystem som vill arbeta bland annat med att implementera EHDS-f\u00f6rordningen i Sverige utifr\u00e5n L\u00e4kemedelsverkets roll och ansvar.\nDina arbetsuppgifter\nI rollen ansvarar du f\u00f6r att samordna och driva arbetet med en effektiv och harmoniserad implementering av EHDS i Sverige. Du bidrar till att s\u00e4kerst\u00e4lla tydliga interna processer och en strukturerad informationsdelning inom L\u00e4kemedelsverket samt till myndighetens aktiva deltagande i det europeiska genomf\u00f6randet av regelverket.\nArbetsuppgifterna omfattar bland annat att:\nsamordna L\u00e4kemedelsverkets interna arbete med EHDS, inklusive planering, informationsdelning och remissarbete\nf\u00f6rbereda, delta i och f\u00f6lja upp myndighetssamverkan inom nationella, nordiska och europeiska forum kopplade till EHDS, exempelvis f\u00f6r marknadskontrollmyndigheter och myndigheter f\u00f6r digital h\u00e4lsa\nutveckla och underh\u00e5lla den nationella samarbetsbilden mellan ber\u00f6rda myndigheter och akt\u00f6rer\nrepresentera L\u00e4kemedelsverket i nordiska och europeiska arbetsgrupper, workshops och andra relevanta forum\nf\u00f6rbereda och f\u00f6lja upp myndighetens deltagande i etablerade samr\u00e5dsforum med ber\u00f6rda akt\u00f6rer\nomv\u00e4rldsbevaka och identifiera prioriterade fr\u00e5gor inom EHDS samt analysera n\u00e4r och hur L\u00e4kemedelsverket beh\u00f6ver engagera sig och bidra med synpunkter\nbidra till f\u00f6rberedelserna inf\u00f6r L\u00e4kemedelsverkets framtida roll som marknadskontrollmyndighet (MKM) och till arbetet med att etablera och drifts\u00e4tta testmilj\u00f6er\nbist\u00e5 med information och v\u00e4gledning r\u00f6rande EHDS, h\u00e4lsodokumentationssystem, medicinteknisk programvara, etc till branschen och h\u00e4lso- och sjukv\u00e5rden.\n\nRollen inneb\u00e4r ett brett kontaktn\u00e4t s\u00e5v\u00e4l internt som med andra svenska myndigheter, EU-institutioner och externa akt\u00f6rer. Arbetet kr\u00e4ver f\u00f6rm\u00e5ga att sj\u00e4lvst\u00e4ndigt driva fr\u00e5gor fram\u00e5t, skapa struktur i komplexa sammanhang och samtidigt bygga goda relationer och effektiv samverkan.\nDin bakgrund\nVi s\u00f6ker dig som har:\nakademisk examen med teknisk, medicinsk data- eller naturvetenskaplig inriktning eller annan f\u00f6r tj\u00e4nsten relevant erfarenhet eller utbildning\narbetslivserfarenhet av programvaror f\u00f6r h\u00e4lso- och sjukv\u00e5rden (som elektroniska patientjournaler, h\u00e4lsodokumentationssystem eller nationella medicinska informationssystem) inom omr\u00e5den som utveckling, f\u00f6rvaltning eller liknande. Det kan omfatta arbete inom industri, h\u00e4lso- och sjukv\u00e5rd, myndighet eller liknande\nl\u00e4tt f\u00f6r att uttrycka dig i tal och skrift p\u00e5 s\u00e5v\u00e4l svenska som engelska.\n\nDet \u00e4r meriterande om du har:\narbetat med och har kunskap om European Health Data Space (EHDS)\nkunskap om medicinteknisk programvara\narbetat med patientjournalsystem och nationella medicinska informationssystem till exempel inom utveckling eller f\u00f6rvaltning\narbetat i rollen som systemarkitekt eller produkt\u00e4gare\narbetat med och har kunskap om General Data Protection Regulation (GDPR) och patientdatalagen med integration till h\u00e4lso- och sjukv\u00e5rdens patientjournalsystem och nationella medicinska informationssystem\narbetat med regelverksfr\u00e5gor inom medicinteknik, in vitrodiagnostik, cybers\u00e4kerhet eller informationss\u00e4kerhet\narbetat inom omr\u00e5dena systemdesign, interoperabilitet, integration eller anv\u00e4ndbarhet g\u00e4llande h\u00e4lsodata\nerfarenhet av policy- eller regelverksarbete arbete p\u00e5 myndighet, s\u00e4rskilt i en samordnande roll med externa akt\u00f6rer \u00e4r meriterande\u00a0\n\nDina personliga egenskaper\nDu \u00e4r initiativtagande, strukturerad samt har en god analytisk och kommunikativ f\u00f6rm\u00e5ga. Du besitter en god\u00a0samarbetsf\u00f6rm\u00e5ga, och kan \u00e4ven arbeta sj\u00e4lvst\u00e4ndigt. Du arbetar m\u00e5linriktat, s\u00e4tter upp tidsramar och har f\u00f6rm\u00e5ga att avsluta enligt plan\u00a0eller kan omprioritera p\u00e5 ett motiverat s\u00e4tt. Du \u00e4r flexibel och har l\u00e4tt att anpassa dig till f\u00f6r\u00e4ndrade omst\u00e4ndigheter.\u00a0Du \u00e4r bra p\u00e5 att v\u00e4xla perspektiv mellan \u00f6vergripande fr\u00e5gor och detaljniv\u00e5.\u00a0Vi l\u00e4gger stor vikt vid personliga egenskaper.\nBra att veta\nSista ans\u00f6kningsdag: 2026-10-05\n\u00a0\nAnst\u00e4llningsform: Tillsvidare\n\u00a0\nTilltr\u00e4de: Enligt \u00f6verenskommelse\n\u00a0\nEnhet: Regelverk och Regulatoriskt st\u00f6d\n\u00a0\nDiarienummer:\u00a02.4.1-2026-073497\n\u00a0\nVi till\u00e4mpar 6 m\u00e5naders provanst\u00e4llning.\nVi v\u00e4rdes\u00e4tter m\u00e5ngfald och v\u00e4lkomnar s\u00f6kande med olika bakgrund.\nP\u00e5 L\u00e4kemedelsverket f\u00e5r du goda f\u00f6ruts\u00e4ttningar f\u00f6r balans i livet. Vi erbjuder dig bland annat flextid, f\u00f6rm\u00e5nliga semestervillkor, friskv\u00e5rdsbidrag samt friskv\u00e5rd p\u00e5 arbetstid. I den m\u00e5n arbetsuppgifterna till\u00e5ter finns det m\u00f6jlighet att delvis arbeta p\u00e5 distans efter \u00f6verenskommelse med chef.\nL\u00e4s mer om de f\u00f6rm\u00e5ner du f\u00e5r hos oss h\u00e4r: https:\/\/www.lakemedelsverket.se\/sv\/om-lakemedelsverket\/jobba-pa-lakemedelsverket\/formaner-hos-oss\u00a0\nL\u00e4kemedelsverket \u00e4r beredskapsmyndighet, vilket inneb\u00e4r att vi genomf\u00f6r vissa bakgrundskontroller i samband med rekryteringar. Du kommer vid en eventuell intervju att beh\u00f6va styrka din identitet samt uppvisa examensbevis och relevanta intyg. All tillsvidareanst\u00e4lld personal vid L\u00e4kemedelsverket \u00e4r krigsplacerad inom myndigheten.\nKontakt\nDu \u00e4r v\u00e4lkommen att kontakta enhetschef Emma Lundberg, emma.m.lundberg@lakemedelsverket.se. Du kan \u00e4ven kontakta de fackliga f\u00f6retr\u00e4darna Jonas Walld\u00e9n, Saco och Pia Wictor, ST. Vi finns p\u00e5 telefon 018-17 46 00 eller n\u00e5s genom e-post fornamn.efternamn@lakemedelsverket.se.\nMer om L\u00e4kemedelsverket\nL\u00e4s mer om v\u00e5rt uppdrag och vad det inneb\u00e4r att arbeta p\u00e5 L\u00e4kemedelsverket h\u00e4r: https:\/\/www.lakemedelsverket.se\/sv\/om-lakemedelsverket\/jobba-pa-lakemedelsverket\nV\u00e4lkommen med din ans\u00f6kan!\nDenna rekrytering sker helt genom L\u00e4kemedelsverkets f\u00f6rsorg. Vi undanber oss d\u00e4rf\u00f6r telefonsamtal fr\u00e5n rekryteringsf\u00f6retag och annonsf\u00f6rs\u00e4ljare.","price":null,"currency":"SEK","status":"active","noindex":true,"location":{"address":"Dag Hammarskj\u00f6lds v\u00e4g 42","full_address":null,"city":"Uppsala","country":"SE","latitude":59.8520701,"longitude":17.7188369},"metadata":{"region":"Uppsala l\u00e4n","duration":"Tills vidare","employer":"L\u00e4kemedelsverket","postcode":"75103","positions":2,"profession":"Handl\u00e4ggare, offentlig f\u00f6rvaltning\/Utredare, offentlig f\u00f6rvaltning","salary_type":"Fast m\u00e5nads- vecko- eller timl\u00f6n","employer_url":"https:\/\/www.lakemedelsverket.se\/sv","scope_of_work":"100\u2013100 %","working_hours":"Heltid","employment_type":"full_time","occupation_field":"Administration, ekonomi, juridik","employer_workplace":"L\u00e4kemedelsverket","experience_required":true,"employment_type_label":"Vanlig anst\u00e4llning"},"user_id":null,"is_sponsored":false,"views_count":0,"ai_views_count":6,"bot_views_count":2,"ai_vendor_counts":{"other":2,"openai":3,"anthropic":1},"visibility":"public","submission_source":null,"submission_ai_name":null,"has_owner_email":true,"can_contact_owner":true,"phone":"018-17 46 00","owner_email":"emma.m.lundberg@lakemedelsverket.se","images":[],"published_at":"2026-09-11T14:11:36+00:00","expires_at":"2026-10-05T23:59:59+00:00","created_at":"2026-09-12T03:26:51+00:00","updated_at":"2026-09-15T02:59:42+00:00"}}