{"data":{"id":94488,"slug":"regulatory-affairs-konsult","type":"job","title":"Regulatory Affairs Consultant","description":"Do you want to help ensure quality in Life Science together with the industry's sharpest minds? Then this is where you belong. With us await assignments that require curiosity, drive for solutions, and sharp expertise\u2014and that give you the chance to develop in new contexts. Together we contribute to a better tomorrow and shape the solutions of the future that make a difference for people and society.\nThis will be your role\nAs a QA\/RA (Quality Assurance and Regulatory Affairs) consultant with us, you will become a key person for our customers. You will support them throughout the entire product lifecycle\u2014from developing quality management systems to creating technical documentation. You will have great scope to influence your own development and the opportunity to lead or participate in projects that make a real difference.\nThe role includes, among other things:\n- Designing regulatory strategies and guiding customers through complex regulations (EU MDR\/IVDR, FDA, MDSAP, etc.).\n- Working with regulatory submissions, applications, and interactions with authorities and notified bodies.\n- Ensuring efficient processes and procedures.\n- Ensuring correct and complete technical documentation.\n- Contributing to clinical and performance evaluations and implementing applicable standards.\n- Being an active part of development projects where regulatory requirements must be integrated early.\n- Sharing knowledge and building expertise together with our experienced RA team.\nHere's how you will excel\nYou have the ability to make complex regulatory requirements understandable and create trust through your communicative style. You are thorough, solution-oriented, and thrive in a role where you switch between strategic thinking and practical execution.\nTo succeed in the role you have:\n- At least 3 years of experience in QA\/RA within medical devices or IVD.\n- A degree from a university or college in Life Science (e.g., MSc in Engineering, BMA, or PhD).\n- Experience writing and updating technical documentation according to MDR\/IVDR as well as clinical\/performance evaluation.\n- Experience writing and adapting processes according to MDR\/IVDR and ISO 13485.\n- Very good language skills in Swedish and English.\n- Documented experience in one or more of the following areas:\n  - EU MDR\/IVDR and associated guidelines.\n  - FDA submissions (510(k), De Novo, PMA) and other regulatory pathways.\n  - MDSAP and international regulatory requirements.\n  - Standards for risk management, safety, and performance (ISO 14971, IEC 60601, IEC 62366, ISO 15189).\nBeing part of Team PV\nWe are a consulting firm passionate about Life Science, from MedTech startups to global pharmaceutical companies. With us you get to follow the entire chain, from manufacturing to healthcare, and work with regulations, audits, project management, and evaluations. What drives us is helping customers achieve their goals and making a real difference for patients and society.\nWith us you get something different. We distinguish ourselves from traditional consulting firms through our unique culture, which stands out and permeates everything we do\u2014and we are extremely proud to be a Great Place to Work, year after year. Some say culture lives in the walls. If ours had, we'd have soft walls. Welcome to us at Plantvision!\nApplication\nDuring the holiday period it may take a bit longer before you hear from us. We will begin the selection and interview process as soon as we return from vacation.\nIf you have questions about this position, feel free to contact Pascal Skoglund at 072 566 99 87 or Pascal.Skoglund@plantvision.se\nDo you have your own company and are interested in collaborating with us as a subcontractor?\nInstead of applying for a specific position, please connect with us via our careers page and indicate that you are interested in working as a subcontractor\u2014we'll get in touch when something suitable comes up.","language":"sv","is_translated":true,"title_original":"Regulatory Affairs konsult","description_original":"Vill du vara med och s\u00e4kerst\u00e4lla kvaliteten inom Life Science tillsammans med branschens skarpaste hj\u00e4rnor? D\u00e5 \u00e4r det h\u00e4r du ska vara. Hos oss v\u00e4ntar uppdrag som kr\u00e4ver nyfikenhet, l\u00f6sningsdriv och vass kompetens och som ger dig chansen att utvecklas i nya sammanhang. Tillsammans bidrar vi till en b\u00e4ttre morgondag och formar framtidens l\u00f6sningar som g\u00f6r skillnad f\u00f6r m\u00e4nniskor och samh\u00e4lle.\nDet h\u00e4r blir din roll\nSom QA\/RA (Quality Assurance och Regulatory Affairs) -konsult hos oss blir du en nyckelperson f\u00f6r v\u00e5ra kunder. Du st\u00f6ttar dem genom hela produktens livscykel \u2013 fr\u00e5n utveckling av kvalitetsledningssystem till framtagning av teknisk dokumentation. Du f\u00e5r stort utrymme att p\u00e5verka din egen utveckling och m\u00f6jlighet att leda eller delta i projekt som g\u00f6r verklig skillnad.\nI rollen ing\u00e5r bland annat att: - Utforma regulatoriska strategier och guida kunder i komplexa regelverk (EU MDR\/IVDR, FDA, MDSAP m.fl.). - Arbeta med regulatoriska ans\u00f6kningar, submissions och interaktion med myndigheter och notified bodies. - S\u00e4kerst\u00e4lla effektiva processer och rutiner. - S\u00e4kerst\u00e4lla korrekt och komplett teknisk dokumentation. - Bidra till klinisk och prestandautv\u00e4rdering samt implementering av till\u00e4mpliga standarder. - Vara en aktiv del i utvecklingsprojekt d\u00e4r regulatoriska krav m\u00e5ste integreras tidigt. - Dela kunskap och bygga kompetens tillsammans med v\u00e5rt erfarna RA-team.\nS\u00e5 h\u00e4r kommer du att briljera\nDu har f\u00f6rm\u00e5gan att g\u00f6ra komplexa regulatoriska krav begripliga och skapar f\u00f6rtroende genom din kommunikativa stil. Du \u00e4r noggrann, l\u00f6sningsorienterad och trivs i en roll d\u00e4r du v\u00e4xlar mellan strategiskt t\u00e4nkande och praktiskt genomf\u00f6rande.\nF\u00f6r att lyckas i rollen har du:\n- Minst 3 \u00e5rs erfarenhet av QA\/RA inom medicinteknik eller IVD. - H\u00f6gskole- eller universitetsexamen inom Life Science (t.ex. civilingenj\u00f6r, BMA eller PhD). - Erfarenhet av att skriva och uppdatera teknisk dokumentation enligt MDR\/IVDR samt klinisk\/prestandautv\u00e4rdering. - Erfarenhet av att skriva och anpassa processer enligt MDR\/IVDR och ISO 13485. - Mycket goda spr\u00e5kkunskaper i svenska och engelska. - Dokumenterad erfarenhet inom ett eller flera av f\u00f6ljande omr\u00e5den: EU MDR\/IVDR och tillh\u00f6rande v\u00e4gledningar. - FDA-ans\u00f6kningar (510(k), De Novo, PMA) och andra regulatoriska pathways. - MDSAP och internationella regulatoriska krav. - Standarder f\u00f6r riskhantering, s\u00e4kerhet och prestanda (ISO 14971, IEC 60601, IEC 62366, ISO 15189).\nAtt vara en del av Team PV\nVi \u00e4r ett konsultbolag som brinner f\u00f6r Life Science, fr\u00e5n MedTech-startups till globala l\u00e4kemedelsbolag. Hos oss f\u00e5r du f\u00f6lja hela kedjan, fr\u00e5n tillverkning till v\u00e5rd, och arbeta med regelverk, revisioner, projektledning och utv\u00e4rderingar. Det som driver oss \u00e4r att hj\u00e4lpa kunder n\u00e5 sina m\u00e5l och g\u00f6ra verklig skillnad f\u00f6r patienter och samh\u00e4lle.\nHos oss f\u00e5r du n\u00e5got annorlunda. Vi skiljer oss fr\u00e5n traditionella konsultbolag genom v\u00e5r unika kultur, den sticker ut och genomsyrar allt vi g\u00f6r och vi \u00e4r extremt stolta \u00f6ver att vara ett Great Place To Work, \u00e5r efter \u00e5r. Vissa s\u00e4ger att en kultur sitter i v\u00e4ggarna. Om v\u00e5r hade gjort det, hade vi haft mjuka v\u00e4ggar. V\u00e4lkommen till oss p\u00e5 Plantvision!\nAns\u00f6kan\nUnder semesterperioden kan det dr\u00f6ja n\u00e5got l\u00e4ngre innan du h\u00f6r ifr\u00e5n oss. Vi p\u00e5b\u00f6rjar arbetet med urval och intervjuer s\u00e5 snart vi \u00e4r tillbaks fr\u00e5n ledigheten.\nOm du har fr\u00e5gor om denna tj\u00e4nst, v\u00e4lkommen att kontakta Pascal Skoglund p\u00e5 072 566 99 87 eller Pascal.Skoglund@plantvision.se\nHar du eget bolag och \u00e4r intresserad av att samarbeta med oss som underkonsult?\nI st\u00e4llet f\u00f6r att s\u00f6ka en specifik tj\u00e4nst, connecta g\u00e4rna med oss via v\u00e5r karri\u00e4rsida och ange att du \u00e4r intresserad av att g\u00e5 som underkonsult \u2013 s\u00e5 h\u00f6r vi av oss n\u00e4r n\u00e5got passande dyker upp.","price":null,"currency":"SEK","status":"active","noindex":true,"location":{"address":"F\u00e4r\u00f6gatan 33","full_address":null,"city":"Kista","country":"SE","latitude":59.401685711652,"longitude":17.946437208993},"metadata":{"region":"Stockholms l\u00e4n","duration":"Tills vidare","employer":"Plantvision AB","postcode":"16451","positions":1,"profession":"Regulatorisk handl\u00e4ggare\/Regulatory affairs specialist","salary_type":"Fast m\u00e5nads- vecko- eller timl\u00f6n","employer_url":"https:\/\/career.plantvision.se","scope_of_work":"100\u2013100 %","working_hours":"Heltid","employment_type":"full_time","occupation_field":"Naturvetenskap","employer_workplace":"Plantvision","experience_required":true,"employment_type_label":"Vanlig anst\u00e4llning"},"user_id":null,"is_sponsored":false,"views_count":30,"ai_views_count":17,"bot_views_count":1,"ai_vendor_counts":{"other":6,"openai":5,"anthropic":4,"microsoft":2},"visibility":"public","submission_source":null,"submission_ai_name":null,"has_owner_email":true,"can_contact_owner":true,"phone":"072 566 99 87","owner_email":"pascal.skoglund@plantvision.se","images":[],"published_at":"2026-06-26T22:34:34+00:00","expires_at":"2026-12-23T23:59:59+00:00","created_at":"2026-06-27T06:16:39+00:00","updated_at":"2026-09-19T02:52:25+00:00"}}