FDA Compliance Stellenangebote


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653 Stellenangebote


Stellenangebote FDA Compliance Jobs gefunden bei Jobbörse StepStone

Stellenangebote FDA Compliance Jobs bei StepStone


Job gestern gefunden OSYPKA AG

Regulatory Affairs Manager (m/w/d)

Rheinfelden Beratungs-/ Consultingtätigkeiten Abgeschlossenes Studium Flexible Arbeitszeiten 30+ Urlaubstage
MEHR[...] Osteuropa, Naher Osten etc. ) . Überwachung und Analyse regulatorischer Anforderungen sowie Bewertung der Auswirkungen auf das Unternehmen. Aufbau und Pflege der PMS/ PMCF- Datenerfassung. Enge Zusammenarbeit mit internen Abteilungen wie Forschung Entwicklung, Qualitätsmanagement und Produktion zur Sicherstellung der regulatorischen Compliance. Durchführung administrativer Tätigkeiten im Bereich Regulatory Affairs. Sicherstellung der Einhaltung des QM- Systems im Arbeitsalltag. Abgeschlossenes Studium (Bachelor/ Master) in Medizintechnik oder einem vergleichbaren Bereich. Mindestens 5 Jahre Berufserfahrung im Bereich Regulatory Affairs oder in vergleichbaren Tätigkeiten. Fundierte Kenntnisse nationaler und internationaler regulatorischer Anforderungen und Richtlinien (z. B. FDA, MDR) . Analytisches Denkvermögen sowie eine strukturierte und detailorientierte Arbeitsweise. Hervorragende Kommunikations- und Verhandlungsfähigkeiten in Deutsch und Englisch. Teamfähigkeit sowie [...]
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Stellenangebot FDA Compliance Job bei Daiichi Sankyo Europe GmbH Job vor 3 Tagen gefunden Daiichi Sankyo Europe GmbH Labeling Strategist (m/f/x) (Global Labeling Strategy Lead) europaweit Beratungs-/ Consultingtätigkeiten Homeoffice möglich Work-Life-Balance
MEHR[...] of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (e. g. , USPI, annotated labeling, medication guides, EU SmPC, PL, CCDS) Independently leads cross functional teams through all labeling discussions with the FDA/ CHMP while ensuring management alignment Strategizes and plans for FDA meetings as needed Acts as point of contact for cross- functional teams on RA labeling issues Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU. Ensure Compliance with Core Data Sheets/ Label Changes: Manages updates to Core Data Sheets for assigned products Manages US/ EU and local [...]
Stellenangebot FDA Compliance Job bei Biotest AG Job vor 5 Tagen gefunden Biotest AG

GMP Compliance Manager (m/w/d) Bereich: Compliance Technikum

Dreieich
MEHR[...] die Produktionsbereiche Naturwissenschaftliches Studium oder vergleichbare Ausbildung Mehrjährige Erfahrung in der pharmazeutischen Industrie Erfahrung in der GMP- gerechten Dokumentation Erfahren im Umgang mit Qualitätssicherungssystemen und Optimierungsmethoden Erfahrung in der Durchführung von Schulungen Mehrjährige Erfahrung in Office und SAP- Umgebungen Idealerweise FDA- Erfahrung Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift Flache Hierarchien sowie angenehmes Arbeitsumfeld Individuelles Einarbeitungsprogramm Attraktive Vergütung Corporate Benefits (Rabatte für unsere Mitarbeitenden) Kantine und Verpflegungszuschuss Kindertagesstätte Bio Nest Fortbildungen und Trainings Kostenfreies Parkhaus für unsere Mitarbeitenden inkl. Lademöglichkeiten für Ihr E- Auto. Biotest AG sucht in Dreieich eine/n GMP Compliance Manager (m/w/d) Bereich: Compliance Technikum (ID- Nummer: 12257702) 40827416 [...]
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Stellenangebot FDA Compliance Job bei ZEISS Job vom 08.10.2024 ZEISS Validierungsmanager für IT Systeme (m/w/x) Oberkochen (Baden- Württemberg) Abgeschlossenes Studium
MEHR[...] Projekten zur Validierung von IT- Systemen, Applikationen und Tools im Rahmen der Systemeinführung oder bei Änderung von Systemen, Applikationen oder Infrastruktur Schulung der internen Betriebsteams zur Aufrechterhaltung validierter/ qualifizierter Systeme im operativen Betrieb Entwicklung, Pflege und kontinuierliche Weiterentwicklung des IT Compliance Frameworks für Validierung (Richtlinien, Prozess und Tooling) Validierungsanforderungen in Projekte einbringen und deren Umsetzung begleiten und überwachen, die Einhaltung der [...] einschlägige Erfahrung im regulierten Umfeld) Erfahrung zur Einführung von IT- Systemen im regulierten Umfeld (Pharmazeutische Industrie, Medizinprodukte, klinische Forschung) und zur Aufrechterhaltung des Validierungsstatus im weiteren Lebenszyklus sehr gute Kenntnisse zu regulatorischen Anforderungen an computergestützte Systeme und entsprechende Infrastruktur (US FDA, 21 CFR Part 11, EU GMP Annex 11, ISO13845, GAMP5) und Computer- System- Validierung Erfahrung zur Entwicklung effizienter und risikobasierter [...]
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Stellenangebot FDA Compliance Job bei PAUL HARTMANN AG Job vom 07.03.2025 PAUL HARTMANN AG

Junior Product Developer- Global Product Development (f/m/d)

Heidenheim Absolventen, Einsteiger, Trainees
MEHR[...] peoples lives better, we should definitely get to know each other- a dynamic and exciting phase full of energy awaits you. Responsibilities: Idea generation for new products and technologies with a focus on electrical engineering Development of new products in compliance with relevant regulations and standards Assist in technical design questions and support project management activities Set up electrical testing setups [...] collaboration and/ or project management Experience in the field of wound care and medical devices Knowledge of the medical devices regulation and the associated subject areas (e. g. , application, design control, biocompatibility, clinical evaluation, risk management, sterilization, CE conformity, FDA, etc. ) Fluent in English and German Benefits: Flexible working conditions, such as flexible working hours and mobile working Attractive [...]
Stellenangebot FDA Compliance Job bei PAUL HARTMANN AG Job vom 07.03.2025 PAUL HARTMANN AG Manager Global Product Development (f/m/d) Heidenheim
MEHR[...] peoples lives better, we should definitely get to know each other- a dynamic and exciting phase full of energy awaits you. Responsibilities: Idea generation for new products and technologies with a focus on electrical engineering Development of new products in compliance with relevant regulations and standards Assist in technical design questions and support project management activities Set up electrical testing setups [...] collaboration and/ or project management Experience in the field of wound care and medical devices Knowledge of the medical devices regulation and the associated subject areas (e. g. , application, design control, biocompatibility, clinical evaluation, risk management, sterilization, CE conformity, FDA, etc. ) Fluent in English and German Benefits: Flexible working conditions, such as flexible working hours and mobile working Attractive [...]
Stellenangebot FDA Compliance Job bei PAUL HARTMANN AG Job vom 07.03.2025 PAUL HARTMANN AG

Ingenieur- Global Product Development (f/m/d)

Heidenheim
MEHR[...] peoples lives better, we should definitely get to know each other- a dynamic and exciting phase full of energy awaits you. Responsibilities: Idea generation for new products and technologies with a focus on electrical engineering Development of new products in compliance with relevant regulations and standards Assist in technical design questions and support project management activities Set up electrical testing setups [...] collaboration and/ or project management Experience in the field of wound care and medical devices Knowledge of the medical devices regulation and the associated subject areas (e. g. , application, design control, biocompatibility, clinical evaluation, risk management, sterilization, CE conformity, FDA, etc. ) Fluent in English and German Benefits: Flexible working conditions, such as flexible working hours and mobile working Attractive [...]
Stellenangebot FDA Compliance Job bei PAUL HARTMANN AG Job vom 07.03.2025 PAUL HARTMANN AG Manager Global Product Development (f/m/d) - Medical Devices Heidenheim
MEHR[...] peoples lives better, we should definitely get to know each other- a dynamic and exciting phase full of energy awaits you. Responsibilities: Idea generation for new products and technologies with a focus on electrical engineering Development of new products in compliance with relevant regulations and standards Assist in technical design questions and support project management activities Set up electrical testing setups [...] collaboration and/ or project management Experience in the field of wound care and medical devices Knowledge of the medical devices regulation and the associated subject areas (e. g. , application, design control, biocompatibility, clinical evaluation, risk management, sterilization, CE conformity, FDA, etc. ) Fluent in English and German Benefits: Flexible working conditions, such as flexible working hours and mobile working Attractive [...]
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Stellenangebote FDA Compliance Jobs gefunden bei Jobbörse JobMESH

Stellenangebote FDA Compliance Jobs bei JobMESH


Stellenangebot FDA Compliance Job bei PAUL HARTMANN AG Job vom 04.01.2025 PAUL HARTMANN AG Junior Product Developer- Global Product Development (f/m/d) Baden- Württemberg Absolventen, Einsteiger, Trainees
MEHR[...] peoples lives better, we should definitely get to know each other- a dynamic and exciting phase full of energy awaits you. Responsibilities: Idea generation for new products and technologies with a focus on electrical engineering Development of new products in compliance with relevant regulations and standards Assist in technical design questions and support project management activities Set up electrical testing setups [...] collaboration and/ or project management Experience in the field of wound care and medical devices Knowledge of the medical devices regulation and the associated subject areas (e. g. , application, design control, biocompatibility, clinical evaluation, risk management, sterilization, CE conformity, FDA, etc. ) Fluent in English and German Benefits: Flexible working conditions, such as flexible working hours and mobile working Attractive [...]
Stellenangebot FDA Compliance Job bei PAUL HARTMANN AG Job vom 04.01.2025 PAUL HARTMANN AG Manager Global Product Development (f/m/d) - Medical Devices Baden- Württemberg
MEHR[...] peoples lives better, we should definitely get to know each other- a dynamic and exciting phase full of energy awaits you. Responsibilities: Idea generation for new products and technologies with a focus on electrical engineering Development of new products in compliance with relevant regulations and standards Assist in technical design questions and support project management activities Set up electrical testing setups [...] collaboration and/ or project management Experience in the field of wound care and medical devices Knowledge of the medical devices regulation and the associated subject areas (e. g. , application, design control, biocompatibility, clinical evaluation, risk management, sterilization, CE conformity, FDA, etc. ) Fluent in English and German Benefits: Flexible working conditions, such as flexible working hours and mobile working Attractive [...]
Stellenangebot FDA Compliance Job bei PAUL HARTMANN AG Job vom 04.01.2025 PAUL HARTMANN AG

Manager Global Product Development (f/m/d)

Baden- Württemberg
MEHR[...] peoples lives better, we should definitely get to know each other- a dynamic and exciting phase full of energy awaits you. Responsibilities: Idea generation for new products and technologies with a focus on electrical engineering Development of new products in compliance with relevant regulations and standards Assist in technical design questions and support project management activities Set up electrical testing setups [...] collaboration and/ or project management Experience in the field of wound care and medical devices Knowledge of the medical devices regulation and the associated subject areas (e. g. , application, design control, biocompatibility, clinical evaluation, risk management, sterilization, CE conformity, FDA, etc. ) Fluent in English and German Benefits: Flexible working conditions, such as flexible working hours and mobile working Attractive [...]
Job vom 04.01.2025 PAUL HARTMANN AG Ingenieur- Global Product Development (f/m/d) Baden- Württemberg
MEHR[...] peoples lives better, we should definitely get to know each other- a dynamic and exciting phase full of energy awaits you. Responsibilities: Idea generation for new products and technologies with a focus on electrical engineering Development of new products in compliance with relevant regulations and standards Assist in technical design questions and support project management activities Set up electrical testing setups [...] collaboration and/ or project management Experience in the field of wound care and medical devices Knowledge of the medical devices regulation and the associated subject areas (e. g. , application, design control, biocompatibility, clinical evaluation, risk management, sterilization, CE conformity, FDA, etc. ) Fluent in English and German Benefits: Flexible working conditions, such as flexible working hours and mobile working Attractive [...]
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