{"data":{"id":222244,"slug":"medtech-consultant-regulatory-affairs-quality-assurance","type":"job","title":"MedTech Consultant - Regulatory Affairs & Quality Assurance","description":"About the company\nAxiom Biotek is a consultancy company within quality and regulatory assurance (QA\/RA) for medical devices, IVD and combination product manufacturers. We help companies build quality management systems, prepare technical documentation and regulatory submissions, and take clients through Notified Body certification.\nOur client base spans both pharmaceutical and medical device manufacturers, in addition to combination products.\nThe role\nWe are looking for a MedTech Consultant to lead our medtech practice. You will own client engagements end to end, from regulatory strategy to audit readiness.\nThis is a senior, client-facing role in a small company. You will be trusted with your own clients from the start, and your regulatory judgment will carry real weight in what we take on.\nMain responsibilities\nAdvise clients on regulatory strategy and route to market across EU MDR, IVDR, FDA and UK requirements\n\n\n\nPrepare and review technical documentation, declarations of conformity and regulatory submissions, including 510(k) and De Novo\n\n\n\nEstablish and maintain ISO 13485 and FDA QMSR compliant quality management systems, and support clients operating GMP pharmaceutical quality systems\n\n\n\nPlan and conduct internal and supplier audits; prepare clients for Notified Body and FDA inspections and support them during assessment\n\n\n\nConfigure and administer client electronic quality management systems\n\n\n\nRequirements\nA degree in life sciences, engineering or a related technical discipline\n\n\n\n5+ years of experience in regulatory affairs and quality assurance for medical devices or IVDs\n\n\n\nDemonstrable experience across both the pharmaceutical and medical device sectors, including GMP and ISO 13485 quality systems\n\n\n\nHands-on working experience with Advantum and Greenlight Guru electronic quality management systems\n\n\n\nWorking knowledge of EU MDR 2017\/745, ISO 13485:2016 and ISO 14971\n\n\n\nExperience preparing technical documentation and leading or supporting certification audits\n\n\n\nFluent professional English, written and spoken","language":"sv","is_translated":true,"title_original":"MedTech Consultant - Regulatory Affairs & Quality Assurance","description_original":"About the company\nAxiom Biotek is a consultancy company within quality and regulatory assurance (QA\/RA) for medical devices, IVD and combination product manufacturers. We help companies build quality management systems, prepare technical documentation and regulatory submissions, and take clients through Notified Body certification.\nOur client base spans both pharmaceutical and medical device manufacturers, in addition to combination products.\nThe role\nWe are looking for a MedTech Consultant to lead our medtech practice. You will own client engagements end to end, from regulatory strategy to audit readiness.\nThis is a senior, client-facing role in a small company. You will be trusted with your own clients from the start, and your regulatory judgement will carry real weight in what we take on.\nMain responsibilities\nAdvise clients on regulatory strategy and route to market across EU MDR, IVDR, FDA and UK requirements\n\n\n\nPrepare and review technical documentation, declarations of conformity and regulatory submissions, including 510(k) and De Novo\n\n\n\nEstablish and maintain ISO 13485 and FDA QMSR compliant quality management systems, and support clients operating GMP pharmaceutical quality systems\n\n\n\nPlan and conduct internal and supplier audits; prepare clients for Notified Body and FDA inspections and support them during assessment\n\n\n\nConfigure and administer client electronic quality management systems\n\n\n\nRequirements\nA degree in life sciences, engineering or a related technical discipline\n\n\n\n5+ years of experience in regulatory affairs and quality assurance for medical devices or IVDs\n\n\n\nDemonstrable experience across both the pharmaceutical and medical device sectors, including GMP and ISO 13485 quality systems\n\n\n\nHands-on working experience with Advantum and Greenlight Guru electronic quality management systems\n\n\n\nWorking knowledge of EU MDR 2017\/745, ISO 13485:2016 and ISO 14971\n\n\n\nExperience preparing technical documentation and leading or supporting certification audits\n\n\n\nFluent professional English, written and spoken","price":null,"currency":"SEK","status":"active","noindex":true,"location":{"address":null,"full_address":null,"city":"\u00c5re","country":"SE","latitude":63.4010888,"longitude":13.0822241},"metadata":{"region":"J\u00e4mtlands l\u00e4n","duration":"Tills vidare","employer":"Axiom Biotek AB","positions":1,"profession":"Kvalitetsingenj\u00f6r, kemiteknik\/Kvalitetstekniker, kemiteknik","salary_type":"Fast m\u00e5nads- vecko- eller timl\u00f6n","scope_of_work":"100\u2013100 %","working_hours":"Heltid","employment_type":"full_time","occupation_field":"Yrken med teknisk inriktning","employer_workplace":"House Be","translation_status":"done","experience_required":true,"employment_type_label":"Tillsvidareanst\u00e4llning (inkl. eventuell provanst\u00e4llning)"},"user_id":null,"is_sponsored":false,"views_count":0,"ai_views_count":3,"bot_views_count":0,"ai_vendor_counts":{"openai":2,"anthropic":1},"visibility":"public","submission_source":null,"submission_ai_name":null,"has_owner_email":true,"can_contact_owner":true,"phone":null,"owner_email":"hello@axiom-biotek.com","images":[],"published_at":"2026-09-19T19:48:35+00:00","expires_at":"2026-09-30T23:59:59+00:00","created_at":"2026-09-20T04:18:10+00:00","updated_at":"2026-09-20T04:35:15+00:00"}}