{"data":{"id":96683,"slug":"regulatory-affairs-specialist","type":"job","title":"Regulatory Affairs Specialist","description":"About the Role\nAs a Global Regulatory Specialist, you will join our Quality & Regulatory Affairs team to help ensure our medical devices and mounting systems meet global regulatory requirements.\n Please note: This is a hybrid role with 1\u20133 days per week onsite at our Stockholm office in \u00d6stermalm, especially during onboarding. Occasional international travel (10\u201320%) may be required and will be communicated in advance.\n In this role you will:\nStreamline regulatory processes and set a roadmap in collaboration with Product & Development, QA, and Operations teams.\nCoordinate with internal and external auditors to support audit readiness.\nReview device classifications and regulatory challenges across markets.\nMaintain and update technical documentation (Annex II & III) and declarations of conformity, including EU Declaration of Conformity, in alignment with the associated technical documentation.\nCoordinate establishment of registrations and device listings with the FDA, Authorized Representatives, and Importers\/Distributors.\nSupport product registrations and market access activities (EU MDR Class I, FDA 510(k)-exempt Class II).\nMonitor regulatory changes and communicate implications to relevant teams.\n What We're Looking For\nWe are looking for a structured and collaborative regulatory professional who enjoys solving problems with a logical approach, works autonomously while contributing to strategic initiatives, and thrives in a dynamic, cross-functional environment.\n We're looking for a detail-oriented and analytical professional with:\nA bachelor's degree in Regulatory Affairs, Life Sciences, Electrical-Electronics or a related field.\nAt least 5 years of experience in medical device regulatory affairs with hands-on experience with EU MDR (Class I) and FDA QSR.\nExperience with regulatory systems, document control tools, and QMS platforms and exposure to technical documentation, internal and external audits for regulatory compliance.\nStrong organization, coordination and communication skills to engage auditors and communicate with stakeholders across functions and levels.\nAbility to break down complex regulatory topics clearly for both technical and non-technical stakeholders.\nProficiency in both spoken and written communication in English.\n Ideal candidates will bring:\nFamiliarity with embedded systems and experience with IEC 62304.\nExperience with EU MDR (Class II\/III).","language":"sv","is_translated":true,"title_original":"Regulatory Affairs Specialist","description_original":"About the Role\nAs a Global Regulatory Specialist, you will join our Quality & Regulatory Affairs team to help ensure our medical devices and mounting systems meet global regulatory requirements.\n Please note: This is a hybrid role with 1\u20133 days per week onsite at our Stockholm office in \u00d6stermalm, especially during onboarding. Occasional international travel (10\u201320%) may be required and will be communicated in advance.\n In this role you will:\nStreamline regulatory processes and set a roadmap in collaboration Product & Development, QA, and Operations teams.\nCoordinate with internal and external auditors to support audit readiness.\nReview device classifications and regulatory challenges across markets.\nMaintain and update technical documentation (Annex II & III) and declarations of conformity, including EU Declaration of Conformity, in alignment with the associated technical documentation.\nCoordinate establishment of registrations and device listings with the FDA, Authorized Representatives, and Importers\/Distributors.\nSupport product registrations and market access activities (EU MDR Class I, FDA 510(k)-exempt Class II).\nMonitor regulatory changes and communicate implications to relevant teams.\n What We\u2019re Looking For\nWe are looking for a structured and collaborative regulatory professional who enjoys solving problems with a logical approach, works autonomously while contributing to strategic initiatives, and thrives in a dynamic, cross-functional environment.\n We\u2019re looking for a detail-oriented and analytical professional with:\nA bachelor\u2019s degree in Regulatory Affairs, Life Sciences, Electrical-Electronics or a related field.\nAt least 5 years of experience in medical device regulatory affairs with hands-on experience with EU MDR (Class I) and FDA QSR.\nExperience with regulatory systems, document control tools, and QMS platforms and exposure to technical documentation, internal and external audits for regulatory compliance\nStrong organization, coordination and communication skills to engage auditors and communicating with stakeholders across functions and levels.\nAbility to break down complex regulatory topics clearly for both technical and non-technical stakeholders.\nProficiency in both spoken and written communication in English.\n Ideal candidates will bring:\nFamiliarity with embedded systems and experience with IEC 62304.\nExperience with EU MDR (Class II\/III).","price":null,"currency":"SEK","status":"active","noindex":true,"location":{"address":null,"full_address":null,"city":null,"country":"SE","latitude":null,"longitude":null},"metadata":{"duration":"12 m\u00e5nader \u2013 upp till 2 \u00e5r","employer":"Celsus Engineering AB","positions":3,"profession":"Regulatorisk handl\u00e4ggare\/Regulatory affairs specialist","salary_type":"Fast m\u00e5nads- vecko- eller timl\u00f6n","scope_of_work":"100\u2013100 %","working_hours":"Heltid","employment_type":"temporary","occupation_field":"Naturvetenskap","employer_workplace":"Celsus Engineering AB","experience_required":true,"employment_type_label":"Tidsbegr\u00e4nsad anst\u00e4llning"},"user_id":null,"is_sponsored":false,"views_count":13,"ai_views_count":14,"bot_views_count":0,"ai_vendor_counts":{"other":4,"openai":5,"anthropic":4,"microsoft":1},"visibility":"public","submission_source":null,"submission_ai_name":null,"has_owner_email":true,"can_contact_owner":true,"phone":null,"owner_email":"support@celsusengineering.se","images":[],"published_at":"2026-06-29T21:17:05+00:00","expires_at":"2026-11-12T23:59:59+00:00","created_at":"2026-06-30T05:40:16+00:00","updated_at":"2026-09-17T03:11:49+00:00"}}