Aktuelle Jobs im Zusammenhang mit Senior Regulatory Affairs Manager - Erlangen, Bayern - Siemens Healthineers AG
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Senior Regulatory Affairs Manager
vor 3 Wochen
Erlangen, Bayern, Deutschland Siemens Healthineers AG VollzeitSenior Regulatory Affairs ManagerAre you passionate about shaping the future of healthcare? At Siemens Healthineers, we're driven to create innovative technologies and services that improve patient outcomes. As a Senior Regulatory Affairs Manager, you'll play a critical role in ensuring our medical devices and diagnostic products meet the highest regulatory...
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Senior Regulatory Affairs Manager
vor 4 Wochen
Erlangen, Bayern, Deutschland Siemens Healthineers AG VollzeitShape the Future of HealthcareAt Siemens Healthineers AG, we're driven to create innovative technologies and services that improve people's lives. As a Senior Regulatory Affairs Manager, you'll play a crucial role in shaping the future of healthcare by ensuring our medical devices and solutions meet the highest regulatory standards.Our Global TeamWe're a...
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Senior Regulatory Affairs Manager
vor 4 Wochen
Erlangen, Bayern, Deutschland Siemens Healthineers AG VollzeitShape the Future of HealthcareAt Siemens Healthineers AG, we're driven to create innovative technologies and services that improve people's lives. As a Senior Regulatory Affairs Manager, you'll play a crucial role in shaping the future of healthcare by ensuring our medical devices and solutions meet the highest regulatory standards.Our Global TeamWe're a...
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Senior Regulatory Affairs Manager
vor 4 Wochen
Erlangen, Bayern, Deutschland Siemens Healthineers AG VollzeitShape the Future of HealthcareAt Siemens Healthineers AG, we're driven to create innovative technologies and services that improve people's lives. As a Senior Regulatory Affairs Manager, you'll play a crucial role in shaping the future of healthcare by ensuring our medical devices and solutions meet the highest regulatory standards.Our Global TeamWe're a...
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Senior Regulatory Affairs Manager
vor 4 Wochen
Erlangen, Bayern, Deutschland Siemens Healthineers AG VollzeitShape the Future of HealthcareAt Siemens Healthineers AG, we're driven to create innovative technologies and services that improve people's lives. As a Senior Regulatory Affairs Manager, you'll play a crucial role in shaping the future of healthcare by ensuring our medical devices and solutions meet the highest regulatory standards.Our Global TeamWe're a...
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Senior Regulatory Affairs Manager
vor 4 Wochen
Erlangen, Bayern, Deutschland Siemens Healthineers AG VollzeitShape the Future of HealthcareAt Siemens Healthineers AG, we're driven to create innovative technologies and services that improve people's lives. As a Senior Regulatory Affairs Manager, you'll play a crucial role in shaping the future of healthcare by ensuring our medical devices and solutions meet the highest regulatory standards.Our Global TeamWe're a...
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Senior Regulatory Affairs Manager
vor 4 Wochen
Erlangen, Bayern, Deutschland Siemens Healthineers AG VollzeitShape the Future of HealthcareAt Siemens Healthineers AG, we're driven to create innovative technologies and services that improve people's lives. As a Senior Regulatory Affairs Manager, you'll play a crucial role in shaping the future of healthcare by ensuring our medical devices and solutions meet the highest regulatory standards.Our Global TeamWe're a...
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Senior Regulatory Affairs Manager
vor 1 Monat
Erlangen, Bayern, Deutschland Siemens Healthineers AG VollzeitShape the Future of HealthcareAt Siemens Healthineers AG, we're driven to create innovative technologies and services that improve patient outcomes. As a Senior Regulatory Affairs Manager, you'll play a critical role in ensuring our medical devices and solutions meet the highest regulatory standards.Our Global TeamWe're a leading global medical technology...
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Senior Regulatory Affairs Manager
vor 1 Monat
Erlangen, Bayern, Deutschland Siemens Healthineers AG VollzeitShape the Future of HealthcareAt Siemens Healthineers AG, we're driven to create innovative technologies and services that improve patient outcomes. As a Senior Regulatory Affairs Manager, you'll play a critical role in ensuring our medical devices and solutions meet the highest regulatory standards.Our Global TeamWe're a leading global medical technology...
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Regulatory Affairs Director
vor 2 Monaten
Erlangen, Bayern, Deutschland Siemens Healthineers AG VollzeitAbout Siemens Healthineers AGWe are a leading global medical technology company dedicated to shaping the future of healthcare. Our innovative technologies and services improve the lives of millions of patients worldwide.Our CultureWe value diversity, open debate, and a willingness to challenge conventional thinking. Our dynamic environment encourages growth,...
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Regulatory Affairs Director
vor 2 Monaten
Erlangen, Bayern, Deutschland Siemens Healthineers AG VollzeitAbout Siemens Healthineers AGWe are a leading global medical technology company dedicated to shaping the future of healthcare. Our innovative technologies and services improve the lives of millions of patients worldwide.Our CultureWe value diversity, open debate, and a willingness to challenge conventional thinking. Our dynamic environment encourages growth,...
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Senior Regulatory Affairs Director
vor 2 Monaten
Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit**About Us**Siemens Healthineers AG is a leading global medical technology company that is shaping the future of healthcare. Our company is driven by a team of 71,000 dedicated colleagues in over 75 countries who are passionate about creating innovative technologies and services that improve patient outcomes.**Our Culture**We value diversity, open debate,...
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Senior Regulatory Affairs Director
vor 2 Monaten
Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit**About Us**Siemens Healthineers AG is a leading global medical technology company that is shaping the future of healthcare. Our company is driven by a team of 71,000 dedicated colleagues in over 75 countries who are passionate about creating innovative technologies and services that improve patient outcomes.**Our Culture**We value diversity, open debate,...
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Senior Regulatory Affairs Manager
vor 1 Woche
Erlangen, Bayern, Deutschland Siemens Healthineers AG VollzeitAt Siemens Healthineers AG, we're shaping the future of healthcare. Our team of 71,000 dedicated colleagues in over 75 countries is driven to create innovative technologies and services that benefit an estimated 5 million patients worldwide.Our Culture:We value different perspectives, open debate, and the will to challenge convention. We lead change in our...
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Regulatory Affairs Expert
vor 2 Wochen
Erlangen, Bayern, Deutschland HumanOptics Holding AG VollzeitRegulatory Affairs SpecialistWir suchen einen erfahrenen Regulatory Affairs Specialist, der unsere Medizinprodukte in nationalen und internationalen Märkten zulassen und registrieren kann.Aufgaben:Zulassung und Registrierung von MedizinproduktenVorbereitung von Unterlagen für die Beglaubigung und LegalisationUnterstützung bei der Pflege und Mitarbeit bei...
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Regulatory Affairs Specialist
vor 3 Wochen
Erlangen, Bayern, Deutschland HumanOptics Holding AG VollzeitJob DescriptionWe are seeking a highly motivated and experienced Regulatory Affairs Specialist (m/w/d) to join our team at HumanOptics Holding AG in Erlangen. As a key member of our regulatory team, you will be responsible for ensuring compliance with EU and national regulations for medical devices.Key ResponsibilitiesConduct market research and analysis to...
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Regulatory Affairs Specialist
vor 3 Wochen
Erlangen, Bayern, Deutschland HumanOptics Holding AG VollzeitJob DescriptionWe are seeking a highly motivated and experienced Regulatory Affairs Specialist (m/w/d) to join our team at HumanOptics Holding AG in Erlangen. As a key member of our regulatory team, you will be responsible for ensuring compliance with EU and national regulations for medical devices.Key ResponsibilitiesConduct market research and analysis to...
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Regulatory Affairs Specialist
vor 2 Wochen
Erlangen, Bayern, Deutschland HumanOptics Holding AG VollzeitRegulatory Affairs Specialist (m/w/d)Wir suchen einen erfahrenen Regulatory Affairs Specialist (m/w/d) für unsere Niederlassung in Erlangen. Als Teil unseres Teams werden Sie sich auf die Zulassung und Registrierung von Medizinprodukten in nationalen und internationalen Märkten konzentrieren.Ihre AufgabenVorbereitung von Unterlagen für die Beglaubigung...
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Regulatory Affairs Specialist
vor 2 Wochen
Erlangen, Bayern, Deutschland HumanOptics Holding AG VollzeitJobbeschreibungWir suchen einen Regulatory Affairs Specialist für unser Team in Erlangen.AufgabenZulassung und Registrierung von Medizinprodukten in nationalen und internationalen MärktenVorbereitung von Unterlagen für die Beglaubigung und LegalisationUnterstützung bei der Pflege und Mitarbeit bei der Erstellung von technischen Produktdokumentationen...
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Regulatory Affairs Specialist
vor 3 Wochen
Erlangen, Bayern, Deutschland HumanOptics Holding AG VollzeitJobbeschreibungWir suchen einen Regulatory Affairs Specialist für unser Team in Erlangen.AufgabenZulassung und Registrierung von Medizinprodukten in nationalen und internationalen MärktenVorbereitung von Unterlagen für die Beglaubigung und LegalisationUnterstützung bei der Pflege und Mitarbeit bei der Erstellung von technischen Produktdokumentationen...
Senior Regulatory Affairs Manager
vor 2 Monaten
We are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team at Siemens Healthineers AG. As a key member of our global regulatory team, you will play a critical role in ensuring compliance with international laws, regulations, and guidelines for in-vivo medical devices and in-vitro diagnostic products.
Key Responsibilities- Provide expert advice to employees on achieving and maintaining legal compliance for global market access of in-vivo and in-vitro diagnostic medical devices
- Support manufacturing units and countries in the analysis and implementation of international regulatory requirements, including product and manufacturer registration, licensing
- Communicate new or changed regulatory requirements to the global Regulatory Affairs Community of Siemens Healthineers
- Represent Siemens Healthineers in national and international industry associations with a focus on medical device regulation, including in-vitro diagnostics
- Conduct negotiations with authorities and other external institutions, and lead international Regulatory Affairs expert teams / task force teams to achieve practical and legally compliant solutions
- Create quality requirement and guidance documents for Regulatory Affairs topics
- Develop and execute worldwide training for employees and external institutions on Regulatory Affairs topics
- Master's degree in natural sciences or engineering, or a master's degree in Regulatory Affairs for medical devices
- More than 5 years of relevant professional experience in Regulatory Affairs for in-vivo and/or in-vitro products
- Familiarity with global regulatory requirements for in-vivo and/or in-vitro products
- Several years of experience and excellent knowledge of current Chinese regulatory requirements for in-vivo products and/or in-vitro diagnostic products, as well as experience in negotiations with Chinese authorities and testing laboratories
- Country-specific regulatory knowledge for other countries, especially Asian and Eastern European countries
- Ideal experience in international association work (e.g., COCIR, MedTech Europe, ZVEI, VDGH)
- Detailed knowledge of European Medical Device Directives and Regulations for in-vivo and/or in-vitro medical devices
- Very good knowledge of international medical device standards
- Well-founded knowledge and experience in QM systems (based on EN ISO 13485, EN ISO 9001, QSR) in process analysis, process management, and process optimization
- Strong communication skills with negotiation-level English language skills in speaking and writing; German language skills are an advantage
- Independent, structured, goal-oriented working style, assertive, and able to interact with different cultures and personalities in international teams
- Entrepreneurial thinking and action, strong motivational ability, analytical penetration, high personal initiative, high resilience, and flexibility
- Willingness to undertake worldwide business trips (max. 10%)
