[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"project-mitarbeiter-mwd-regulatory-affairs-2":3,"similar-mitarbeiter-mwd-regulatory-affairs-2":31},{"id":4,"slug":5,"title":6,"skills":7,"budget":16,"duration":16,"location":17,"onsitePercent":18,"contractType":19,"foundAt":20,"category":21,"description":24,"rawText":25,"webTitle":26,"webText":27,"language":28,"projectId":29,"sourceUrl":30},11735,"mitarbeiter-mwd-regulatory-affairs-2","Mitarbeiter (m\u002Fw\u002Fd) Regulatory Affairs",[8,9,10,11,12,13,14,15],"Regulatory Affairs","Technische Dokumentation","MDD","MDR","Medizintechnik","Qualitätsmanagement","Analyse","Bewertung",null,"Aschaffenburg, Bayern",50,"permanent","2026-06-09T08:26:38+00:00",{"id":22,"slug":23,"label":12},14,"medical_tech","Unterstützung bei der Erstellung technischer Dokumentation für Medizintechnikprodukte und Sicherstellung regulatorischer Anforderungen (MDD\u002FMDR). Analyse internationaler Vorschriften und Implementierung von Maßnahmen zur Verkehrsfähigkeit. Erstellung von Geräteprüfberichten und Verwaltung von Verfahrensanweisungen.","Mitarbeiter (m\u002Fw\u002Fd) Regulatory Affairs\nProjektnummer: FE66-40028-F\nStandort: Aschaffenburg, Bayern\nArbeitsweise: Hybrid\nLaufzeit: Keine Angabe\nStartdatum: Keine Angabe\n\nIhr Aufgabengebiet:\n- Unterstützung bei der Erstellung der technischen Dokumentation für Medizintechnikprodukte\n\n- Unterstützung der regelmäßigen Aktualitätsprüfung von Technical Files insb. Sicherstellung der Essential Requirements zur CE Konformitätserklärung MDD und Erfüllung der \"General Safety and Performance Requirements\" zur CE Konformitätserklärung MDR\n\n- Erstellung von Geräteprüfberichten für die technische Dokumentation\n\n- Analyse und Bewertung internationaler regulatorischer Anforderungen\n\n- Implementierung von Maßnahmen zur Sicherstellung der internationalen Verkehrsfähigkeit von Medizintechnikprodukten\n\n- Erstellung, Überarbeitung und Pflege von Verfahrensanweisungen sowie Überwachung von Änderungen an SOPs\n\nIhr Profil:\n- Abgeschlossenes Hochschulstudium, vorzugsweise im Bereich Medizintechnik oder vergleichbar\n\n- Erste Erfahrungen in der technischen Dokumentation und den regulatorischen Anforderungen von Medizinprodukten\n\n- Erfahrung im Bereich RD, QM oder Zulassung von komplexen Systemen von Vorteil\n\n- Gute Deutsch- und Englischkenntnisse\n\nSkills: Analyse, Bewertung, Dokumentation, Implementierung, MDD, MDR, Medizintechnik, QM, Regulatory Affairs\n\nAnsprechpartner:\nSarina von Schwartzenberg\nTalent Acquisition Lead\nFERCHAU GmbH, Niederlassung Wiesbaden Pharma & Life Science\nAlte Schmelze 18-20\n65201 Wiesbaden\n+49 611 238 7750\nwiesbaden-pls@ferchau.com","Mitarbeiter Regulatory Affairs (m\u002Fw\u002Fd)","Wir suchen einen engagierten Mitarbeiter (m\u002Fw\u002Fd) im Bereich Regulatory Affairs für unseren Standort in Aschaffenburg. In dieser Rolle unterstützen Sie unser Team bei der Verwaltung und Optimierung regulatorischer Prozesse im Medizintechniksektor.\n\nIhre Aufgaben umfassen die Unterstützung bei der Erstellung technischer Dokumentation für Medizintechnikprodukte sowie die regelmäßige Überprüfung und Aktualisierung von Technical Files. Sie stellen sicher, dass alle Essential Requirements für CE-Konformitätserklärungen gemäß MDD und MDR erfüllt sind und die General Safety and Performance Requirements eingehalten werden.\n\nWeitere Verantwortungen sind die Erstellung von Geräteprüfberichten, die Analyse und Bewertung internationaler regulatorischer Anforderungen sowie die Implementierung von Maßnahmen zur Sicherstellung der internationalen Verkehrsfähigkeit von Produkten. Sie erstellen, überarbeiten und pflegen Verfahrensanweisungen und überwachen Änderungen an SOPs.\n\nFür diese Position bringen Sie ein abgeschlossenes Hochschulstudium mit, vorzugsweise in Medizintechnik oder einem vergleichbaren Fachbereich. Erste Erfahrungen in technischer Dokumentation und regulatorischen Anforderungen von Medizinprodukten sind erforderlich. Erfahrung in den Bereichen Forschung & Entwicklung, Qualitätsmanagement oder Zulassung komplexer Systeme ist von Vorteil.\n\nSie verfügen über gute Deutsch- und Englischkenntnisse und bringen Stärken in Analyse, Bewertung und Dokumentation mit. Die Position wird hybrid ausgeübt und bietet Ihnen Flexibilität bei der Arbeitsgestaltung.","de","FE66-40028-F","https:\u002F\u002Ftouch.ferchau.com\u002Fde\u002Fde\u002Fprojekt\u002F335677",{"items":32},[33,59,76,88,109,125,143,161,182,193,210,223,234,247,259],{"id":34,"slug":35,"title":36,"skills":37,"budget":16,"duration":16,"location":54,"onsitePercent":55,"contractType":56,"foundAt":57,"category":58},11902,"it-anwendungsbetreuer-mwd-2","IT-Anwendungsbetreuer (m\u002Fw\u002Fd)",[38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53],"Fachinformatiker","Medizinische IT-Systeme","AIS","LIS","Jira","ServiceNow","Netzwerktechnik","TCP\u002FIP","Firewalls","VPN","IT-Sicherheit","Microsoft Windows Server","RDP","Citrix","Anwenderschulungen","Dokumentation","Rosenheim",100,"contracting","2026-06-09T14:27:06+00:00",{"id":22,"slug":23,"label":12},{"id":60,"slug":61,"title":62,"skills":63,"budget":16,"duration":16,"location":73,"onsitePercent":55,"contractType":56,"foundAt":74,"category":75},11872,"chemielaborant-qualitaetskontrolle-mwd","Chemielaborant Qualitätskontrolle (m\u002Fw\u002Fd)",[64,65,66,67,68,69,70,71,72,53],"Chemielaborant","Qualitätskontrolle","GMP","HPLC","GC","Chromeleon","CTA","PTA","CAPA","Miesbach, Bayern","2026-06-09T13:25:36+00:00",{"id":22,"slug":23,"label":12},{"id":77,"slug":78,"title":79,"skills":80,"budget":16,"duration":16,"location":73,"onsitePercent":55,"contractType":19,"foundAt":86,"category":87},11871,"chemielaborant-lab-technician-mwd-analytical-development","Chemielaborant \u002F Lab Technician (m\u002Fw\u002Fd) Analytical Development",[81,67,68,82,83,69,66,53,84,85],"Analytik","Methodenentwicklung","Validierung analytischer Methoden","Chromatographie","Spektrometrie","2026-06-09T13:25:25+00:00",{"id":22,"slug":23,"label":12},{"id":89,"slug":90,"title":91,"skills":92,"budget":16,"duration":105,"location":16,"onsitePercent":106,"contractType":56,"foundAt":107,"category":108},11773,"sustaining-engineer-mwd","Sustaining Engineer (m\u002Fw\u002Fd)",[93,94,95,96,97,98,99,100,101,102,103,104],"Medical Device Engineering","Design Authority","Non Conformance Report (NCR) Assessment","Design for Manufacturing","Regulatory Compliance (QSR, GMP, ISO)","Change Management","Project Management","Engineering Testing and Analysis","Vendor Management","Cross-functional Coordination","English","German","6 Monate, Start 01.07.2026",0,"2026-06-09T09:30:21+00:00",{"id":22,"slug":23,"label":12},{"id":110,"slug":111,"title":112,"skills":113,"budget":16,"duration":16,"location":122,"onsitePercent":18,"contractType":56,"foundAt":123,"category":124},11741,"junior-quality-engineer-medical-devices-mwd","Junior Quality Engineer Medical Devices (m\u002Fw\u002Fd)",[114,115,116,117,118,119,120,121],"Audits","Elektrotechnik","Fehleranalyse","Lösungskompetenz","Management","Medical Devices","Deutsch","Englisch","Aschaffenburg","2026-06-09T08:27:29+00:00",{"id":22,"slug":23,"label":12},{"id":126,"slug":127,"title":128,"skills":129,"budget":16,"duration":16,"location":140,"onsitePercent":18,"contractType":56,"foundAt":141,"category":142},11740,"manager-gxp-compliance-mwd","Manager GxP Compliance (m\u002Fw\u002Fd)",[130,131,132,133,72,134,135,136,137,138,139,120,121],"GxP","SOP","Change Control","Deviation","Risk Management","CSV","Qualifizierung","Validierung","Audit","Life Science","Mainz, Rheinland-Pfalz","2026-06-09T08:27:21+00:00",{"id":22,"slug":23,"label":12},{"id":144,"slug":145,"title":146,"skills":147,"budget":16,"duration":16,"location":158,"onsitePercent":18,"contractType":56,"foundAt":159,"category":160},11739,"device-engineer-mwd","Device Engineer (m\u002Fw\u002Fd)",[148,53,149,150,151,152,153,154,155,156,157],"Design","Entwicklung","Entwicklungsprozesse","Integration","Kombinationsprodukte","Koordinierung","Planung","Risikomanagement","Umsetzung","Usability","Ingelheim am Rhein","2026-06-09T08:27:13+00:00",{"id":22,"slug":23,"label":12},{"id":162,"slug":163,"title":164,"skills":165,"budget":16,"duration":16,"location":179,"onsitePercent":18,"contractType":56,"foundAt":180,"category":181},11738,"product-lifecycle-engineer-mwd-medizintechnik","Product Lifecycle Engineer (m\u002Fw\u002Fd) Medizintechnik",[166,167,115,149,168,169,170,171,172,12,173,174,175,176,177,178],"Anlagenbau","Einkauf","Feinwerktechnik","Hydraulik","Maschinenbau","Mechanik","Medizinprodukte","Pneumatik","Produktion","QM","Service","Steuerung","Teamfähigkeit","Frankfurt am Main","2026-06-09T08:27:03+00:00",{"id":22,"slug":23,"label":12},{"id":183,"slug":184,"title":185,"skills":186,"budget":16,"duration":16,"location":179,"onsitePercent":18,"contractType":19,"foundAt":191,"category":192},11737,"mitarbeiter-mwd-customer-service-pharma","Mitarbeiter (m\u002Fw\u002Fd) Customer Service Pharma",[187,188,189,190,114,120,121],"Customer Service","SAP","MS Office","Auftragsabwicklung","2026-06-09T08:26:54+00:00",{"id":22,"slug":23,"label":12},{"id":194,"slug":195,"title":196,"skills":197,"budget":16,"duration":16,"location":207,"onsitePercent":18,"contractType":56,"foundAt":208,"category":209},11734,"referent-mwd-substance-product-management","Referent (m\u002Fw\u002Fd) Substance & Product Management",[198,199,200,201,202,203,204,205,206],"Chemie","Biologie","CLP-Verordnung","GHS","SAP-EHS","Datenpflege","REACH","Gefahrstoffeinstufung","Sicherheitsdatenblätter","Hanau, Hessen","2026-06-09T08:26:31+00:00",{"id":22,"slug":23,"label":12},{"id":211,"slug":212,"title":213,"skills":214,"budget":16,"duration":16,"location":179,"onsitePercent":18,"contractType":19,"foundAt":221,"category":222},11733,"junior-projektmanager-mwd-klinische-studien","(Junior) Projektmanager (m\u002Fw\u002Fd) klinische Studien",[215,216,217,218,219,121,220],"Projektmanagement","Projektplanung","Budgetierung","Angebotserstellung","Klinische Studien","Analytisches Denken","2026-06-09T08:26:21+00:00",{"id":22,"slug":23,"label":12},{"id":224,"slug":225,"title":226,"skills":227,"budget":16,"duration":16,"location":207,"onsitePercent":55,"contractType":231,"foundAt":232,"category":233},11732,"chemikant-mwd-pharmazeutische-produktion","Chemikant (m\u002Fw\u002Fd) pharmazeutische Produktion",[228,229,66,230,174,131,121,120],"Chemikant:in Ausbildung","EDV","Kommunikationsfähigkeit","temp_work","2026-06-09T08:26:13+00:00",{"id":22,"slug":23,"label":12},{"id":235,"slug":236,"title":237,"skills":238,"budget":16,"duration":16,"location":179,"onsitePercent":18,"contractType":56,"foundAt":245,"category":246},11731,"junior-qa-manager-mwd-pharma","Junior QA Manager (m\u002Fw\u002Fd) Pharma",[132,239,240,241,242,198,199,133,243,121,244],"cGMP","ISO","JIRA","Pharmazie","LIMS","Koordination","2026-06-09T08:26:03+00:00",{"id":22,"slug":23,"label":12},{"id":248,"slug":249,"title":250,"skills":251,"budget":16,"duration":16,"location":179,"onsitePercent":55,"contractType":56,"foundAt":257,"category":258},11730,"mitarbeiter-mwd-quality-operations-pharma","Mitarbeiter (m\u002Fw\u002Fd) Quality Operations Pharma",[67,68,252,253,66,254,255,121,256],"Methodenvalidierung","Instrumentelle Analytik","Stabilitätsstudien","MS-Office","SOP-Erstellung","2026-06-09T08:25:54+00:00",{"id":22,"slug":23,"label":12},{"id":260,"slug":261,"title":262,"skills":263,"budget":16,"duration":16,"location":179,"onsitePercent":55,"contractType":56,"foundAt":269,"category":270},11729,"servicetechniker-mwd-medizintechnik","Servicetechniker (m\u002Fw\u002Fd) Medizintechnik",[12,264,172,189,265,266,121,267,268],"Technischer Service","Excel","Lotus Notes","Beratung","Kommunikation","2026-06-09T08:25:45+00:00",{"id":22,"slug":23,"label":12}]