[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"project-regulatory-affairs-manager-mwd":3,"similar-regulatory-affairs-manager-mwd":30},{"id":4,"slug":5,"title":6,"skills":7,"budget":16,"duration":17,"location":18,"onsitePercent":19,"contractType":20,"foundAt":21,"category":22,"description":25,"rawText":26,"language":27,"projectId":28,"sourceUrl":29},5291,"regulatory-affairs-manager-mwd","Regulatory Affairs Manager (m\u002Fw\u002Fd)",[8,9,10,11,12,13,14,15],"Regulatory Affairs","MDR","ISO 13485","FDA","Medizintechnik","Risikomanagement","Change-Control","Compliance","80.000 EUR p.a.",null,"Bayern",50,"permanent","2026-05-21T16:38:54+00:00",{"id":23,"slug":24,"label":12},14,"medical_tech","Suche nach einem Regulatory Affairs Manager für Medizinprodukte mit Expertise in MDR, ISO 13485 und FDA-Regularien. Verantwortung für Zulassungsdokumente, Compliance-Überwachung und Beratung interner Abteilungen. Ansprechpartner für Behörden und Koordination von Audits.","-\n-\n-\n-\n-\n-\nRegulatory Affairs Manager (m\u002Fw\u002Fd)\n\nBayern\n\nRegulatory Affairs Manager (m\u002Fw\u002Fd)\n\nExklusivmandat: Regulatory Affairs Manager (m\u002Fw\u002Fd)\n\nZusammenfassung\n\nWir bei Zabel verstehen, wie entscheidend die richtige Position für Ihre berufliche Weiterentwicklung ist. Aktuell suchen wir im Auftrag eines unserer namhaften Kunden einen Regulatory Affairs Manager (m\u002Fw\u002Fd) mit Expertise im Bereich Medizinprodukte. Wenn Sie Leidenschaft für Qualität und regulatorische Anforderungen mitbringen, sind Sie bei uns genau richtig. Wir freuen uns darauf, Sie auf Ihrem nächsten Karriereschritt zu begleiten!\n\nAufgaben und Verantwortlichkeiten\n\n- Verantwortung für die Erstellung, Koordination und Einreichung von Zulassungsdokumenten für Medizinprodukte gemäß nationaler und internationaler Regularien (z. B. MDR, ISO 13485, FDA)\n\n- Überwachung und Sicherstellung der Compliance mit regulatorischen Anforderungen entlang des gesamten Produktlebenszyklus\n\n- Beratung und Unterstützung der internen Abteilungen bei regulatorischen Fragestellungen, insbesondere in den Bereichen Entwicklung und Qualitätssicherung\n\n- Durchführung und Dokumentation von Risikomanagement- und Change-Control-Prozessen in Übereinstimmung mit den regulatorischen Vorgaben\n\n- Ansprechpartner für Zulassungsbehörden und Benannte Stellen sowie Koordination von Audits und Inspektionen\n\nFachliche Anforderungen\n\n- Abgeschlossenes Studium im Bereich Medizintechnik, Ingenieurwesen, Naturwissenschaften oder eine vergleichbare Qualifikation\n\n- Mehrjährige Erfahrung im Bereich Regulatory Affairs, vorzugsweise in der Medizintechnikbranche\n\n- Fundierte Kenntnisse der regulatorischen Anforderungen (MDR, ISO 13485, FDA-Regularien)\n\n- Fähigkeit, komplexe regulatorische Anforderungen zu analysieren und praktikable Lösungen zu entwickeln\n\n- Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift sowie ausgeprägte Kommunikationsfähigkeiten\n\nIhre Vorteile\n\n- Eine anspruchsvolle und abwechslungsreiche Tätigkeit\n\n- Attraktive Vergütung sowie umfangreiche Zusatzleistungen, z. B. betriebliche Altersvorsorge und Erfolgsbeteiligung\n\n- Flexible Arbeitszeiten und Home-Office-Möglichkeiten zur Förderung einer ausgewogenen Work-Life-Balance\n\n- Familienfreundlichkeit und Kollegiale Unterstützungkultur\n\n- Ein modernes Arbeitsumfeld in einem internationalen und motivierten Team\n\nBei Zabel legen wir Wert auf einen einfachen und transparenten Bewerbungsprozess. Sobald wir Ihre Unterlagen erhalten, setzen wir uns zeitnah mit Ihnen in Verbindung, um ein persönliches Gespräch zu vereinbaren. Unser Ziel? Sie optimal auf die Position vorzubereiten und erfolgreich bei unserem Kunden vorzustellen. Bewerben Sie sich jetzt – wir freuen uns, Sie kennenzulernen!Ihr Ansprechpartner: Fabio ZöllerMail: E-Mail: f.zoeller@zabelglobal.com f.zoeller@zabelglobal.com\n\nExpertise\n\nRegulatory Affairs\nSkills\n\nMedTech - MDRMedTech - ISO13485\nLocation\n\nShare\n\n- LinkedIn\n- X (Twitter)\n- Facebook\n- WhatsApp\n-\nJob Reference\n\n1082\n\nDate Posted\n\n3 February 2025\n\nIndustry\n\nEngineering - Medical Devices\n\nEmployment\n\nPermanent\n\nWorking Location\n\nHybrid\n\nLevel\n\nMid-Level\n\nExperience\n\n3 years\n\nCompensation\n\n€ 80.000 p.a.\n\nLanguage\n\nGerman, English\n\nFabio Zöller\n\nConsultant\n\n+49 175 5959377\n\nE-Mail: f.zoeller@zabelglobal.com f.zoeller@zabelglobal.com\n\nhttps:\u002F\u002Fwww.linkedin.com\u002Fin\u002Ffabio-z%C3%B6ller\u002F\n\nCONTACT US\n\nCONTACT OUR TEAM","de","1082","https:\u002F\u002Fwww.zabelglobal.com\u002Fjobs\u002F1082-regulatory-affairs-manager-m-w-d",{"items":31},[32,47,59,74,89,101,112,126,138,160,175,194,214,229,247],{"id":33,"slug":34,"title":35,"skills":36,"budget":17,"duration":41,"location":42,"onsitePercent":43,"contractType":44,"foundAt":45,"category":46},5295,"freiberuflicher-konstrukteur-3d-zeichnungen","Freiberuflicher Konstrukteur - 3D Zeichnungen",[37,38,39,40,12],"SolidWorks","3D-Konstruktion","Maschinenbau","Konstruktionstechnik","Dezember \u002F Januar 2025","Baden-Württemberg",2,"contracting","2026-05-21T16:39:19+00:00",{"id":23,"slug":24,"label":12},{"id":48,"slug":49,"title":50,"skills":51,"budget":17,"duration":17,"location":56,"onsitePercent":19,"contractType":20,"foundAt":57,"category":58},5293,"quality-spezialist-mwd-fuer-die-medizintechnik","Quality Spezialist (m\u002Fw\u002Fd) für die Medizintechnik",[10,52,12,53,54,55],"Qualitätssicherung","CAPA-Maßnahmen","Qualitätsmanagement","Audits","Karlsruhe","2026-05-21T16:39:08+00:00",{"id":23,"slug":24,"label":12},{"id":60,"slug":61,"title":62,"skills":63,"budget":17,"duration":17,"location":70,"onsitePercent":71,"contractType":20,"foundAt":72,"category":73},5292,"senior-expert-validation-engineer-mwd","(Senior) Expert Validation Engineer (m\u002Fw\u002Fd)",[64,65,66,67,12,68,54,69],"Validation Engineering","Prozessentwicklung","ISO13485","Lean\u002FSix Sigma","Produktionsprozesse","Englisch","Nordrhein-Westfalen",80,"2026-05-21T16:39:01+00:00",{"id":23,"slug":24,"label":12},{"id":75,"slug":76,"title":77,"skills":78,"budget":86,"duration":17,"location":18,"onsitePercent":19,"contractType":20,"foundAt":87,"category":88},5290,"senior-quality-manager-rd","Senior Quality Manager (R&D)",[79,80,81,82,83,84,10,85,13],"Quality Management","Quality Assurance","Quality Control","MedTech - MDR","MedTech - ISO13485","ISO 14971","EU MDR","100.000 EUR p.a.","2026-05-21T16:38:50+00:00",{"id":23,"slug":24,"label":12},{"id":90,"slug":91,"title":92,"skills":93,"budget":98,"duration":17,"location":18,"onsitePercent":19,"contractType":20,"foundAt":99,"category":100},5289,"quality-manager-mwd","Quality-Manager (m\u002Fw\u002Fd)",[79,80,81,82,83,94,95,96,97,55],"Six-Sigma","LEAN","8D","Qualitätsmanagementsystem","90.000 EUR p.a.","2026-05-21T16:38:43+00:00",{"id":23,"slug":24,"label":12},{"id":102,"slug":103,"title":104,"skills":105,"budget":109,"duration":17,"location":42,"onsitePercent":19,"contractType":20,"foundAt":110,"category":111},5288,"head-of-quality-assurance-mwd","Head of Quality Assurance (m\u002Fw\u002Fd)",[80,79,82,83,106,10,107,54,108],"ISO 9001","Führungserfahrung","Medizinprodukte","110.000 EUR p.a.","2026-05-21T16:38:34+00:00",{"id":23,"slug":24,"label":12},{"id":113,"slug":114,"title":115,"skills":116,"budget":17,"duration":123,"location":42,"onsitePercent":19,"contractType":44,"foundAt":124,"category":125},5287,"freiberuflicher-firmware-entwickler","Freiberuflicher Firmware-Entwickler",[117,118,119,120,121,122,10,12],"Firmware-Entwicklung","C\u002FC++","Embedded Systems","Microcontroller-Programmierung","IEC 60601","IEC 62304","Anfang Januar","2026-05-21T16:38:30+00:00",{"id":23,"slug":24,"label":12},{"id":127,"slug":128,"title":129,"skills":130,"budget":17,"duration":17,"location":135,"onsitePercent":19,"contractType":44,"foundAt":136,"category":137},5201,"technischer-redakteur-konstruktion-solidworks-mwd","Technischer Redakteur Konstruktion \u002F SolidWorks (m\u002Fw\u002Fd)",[37,131,132,12,9,133,134,39],"3D-CAD","Technische Dokumentation","Konstruktion","MS Office","Lübeck","2026-05-21T15:25:53+00:00",{"id":23,"slug":24,"label":12},{"id":139,"slug":140,"title":141,"skills":142,"budget":17,"duration":154,"location":155,"onsitePercent":156,"contractType":157,"foundAt":158,"category":159},5099,"ivd-product-lead-external-manufacturing","IVD Product Lead External Manufacturing",[143,10,144,145,146,147,148,149,150,151,152,153],"IVD product management","IVDR","FDA 21 CFR","Product specification","Production process specification","Leadership","German","English","Engineering","Natural Science","OPEX\u002FCAPEX","12++ months","Rotkreuz",90,"temp_work","2026-05-21T12:06:25+00:00",{"id":23,"slug":24,"label":12},{"id":161,"slug":162,"title":163,"skills":164,"budget":17,"duration":172,"location":17,"onsitePercent":19,"contractType":44,"foundAt":173,"category":174},5005,"cmc-regulatory-expert-mwd-fokus-peptid-parenterale-originalpraeparate-2","CMC Regulatory Expert (m\u002Fw\u002Fd) – Fokus Peptid \u002F parenterale Originalpräparate",[165,166,167,168,8,169,170,171],"CMC-Dokumentation","Originalpräparate","parenterale Peptid-Produkte","Modul 3 (Quality)","EMA\u002FFDA Anforderungen","Dossier-Erstellung","Manufacturing Change Control","bis mindestens 31.12.2026 (Option auf Verlängerung)","2026-05-21T08:16:18+00:00",{"id":23,"slug":24,"label":12},{"id":176,"slug":177,"title":178,"skills":179,"budget":17,"duration":190,"location":191,"onsitePercent":19,"contractType":44,"foundAt":192,"category":193},5004,"senior-analytical-scientist-hplcuhplc-biologics-2","Senior Analytical Scientist (HPLC\u002FUHPLC, Biologics)",[180,181,182,183,184,185,186,187,188,189],"HPLC","UHPLC","Chromatographie","Biologics","Proteinbiochemie","Methodenentwicklung","Thermo Fisher UHPLC-Systeme","Chromeleon Software","SEC","RP","ca. 9 Monate","Österreich","2026-05-21T08:16:11+00:00",{"id":23,"slug":24,"label":12},{"id":195,"slug":196,"title":197,"skills":198,"budget":17,"duration":17,"location":210,"onsitePercent":211,"contractType":44,"foundAt":212,"category":213},4585,"laborant-zellkultur-mwd","Laborant Zellkultur (m\u002Fw\u002Fd)",[199,200,201,202,203,204,205,206,207,208,209],"Anlagen","Auswertung","Entwicklung","Fermentation","GMP","Herstellung","Optimierung","Planung","Teamfähigkeit","Zellkultur","Zelllinien","Biberach an der Riß",100,"2026-05-20T02:26:18+00:00",{"id":23,"slug":24,"label":12},{"id":215,"slug":216,"title":217,"skills":218,"budget":17,"duration":17,"location":210,"onsitePercent":211,"contractType":44,"foundAt":227,"category":228},4550,"technischer-assistent-hplc-analytik-mwd","Technischer Assistent HPLC-Analytik (m\u002Fw\u002Fd)",[180,203,219,220,221,222,223,224,225,226],"Analytik","Methodenvalidierung","Dokumentation","Empower","LabWare-LIMS","MS-Office","Chemielaborant","Biologielaborant","2026-05-19T16:25:57+00:00",{"id":23,"slug":24,"label":12},{"id":230,"slug":231,"title":232,"skills":233,"budget":17,"duration":243,"location":244,"onsitePercent":156,"contractType":44,"foundAt":245,"category":246},4527,"project-engineer-mwd-pharma","Project Engineer (m\u002Fw\u002Fd) Pharma",[234,235,236,237,238,239,240,39,241,242],"Projektmanagement","GMP-Kenntnisse","Pharmazeutische Industrie","Verfahrenstechnik","Biotechnologie","Pharmatechnik","Chemieingenieurwesen","Englischkenntnisse","Kommunikationsfähigkeit","6 Monate","Ludwigshafen am Rhein","2026-05-19T14:35:32+00:00",{"id":23,"slug":24,"label":12},{"id":248,"slug":249,"title":250,"skills":251,"budget":17,"duration":266,"location":267,"onsitePercent":211,"contractType":44,"foundAt":268,"category":269},4515,"testing-von-medizingeraeten","Testing von Medizingeräten",[252,253,254,255,256,257,258,259,260,261,262,263,264,265],"Testing","Testspezifikation","Jira","Python","C","C#","SQL","ISTQB","Elektronik","Informatik","Requirements Management","Polarion","Netzwerk","Datenbanken","13 Monate","Bensheim","2026-05-19T14:26:47+00:00",{"id":23,"slug":24,"label":12}]