Regulatory Affairs Expert for Digital Health

vor 2 Wochen

Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

Role Overview

As a Senior Regulatory Affairs Manager with Siemens Healthineers, you will play a crucial role in ensuring the compliance of our in-vivo medical devices and in-vitro diagnostic products with international regulatory requirements.

Key Responsibilities

  • Provide active and practical support to manufacturing units and countries in analyzing and implementing international regulatory requirements
  • Communicate new or changed regulatory requirements to the global Regulatory Affairs Community and lead international expert teams to achieve practical and legally compliant solutions
  • Advise employees on achieving and maintaining legal compliance for global market access of in-vivo and in-vitro diagnostic medical devices
  • Develop new and future-oriented strategies for digitalization of processes, particularly in Regulatory Affairs and Technical Standards, to improve market access and maintenance
  • Contribute to identifying new digital transformation opportunities in Regulatory Affairs and implement them in respective projects

Requirements

  • Degree in natural sciences or engineering; alternatively, degree in Regulatory Affairs for medical devices
  • Several years of substantial relevant professional experience in Regulatory Affairs for in-vivo and/or in-vitro products
  • Experience in AI/LLM applications and digital solutions within Regulatory Affairs Processes
  • Familiarity with global regulatory requirements for in-vivo and/or in-vitro products and good regulatory knowledge of the European Medical Device Directives and Regulations
  • Well-founded knowledge and experience in QM systems (EN ISO 13485, EN ISO 9001, QSR) in process analysis, management, and optimization
  • Practical experience in globally acting matrix organizations leading projects and interdisciplinary cross-functional global project teams

Desired Attributes and Skills

  • 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, assertiveness, and ability to interact with different cultures and personalities in international teams
  • Personal strengths include entrepreneurial thinking and action, strong motivational ability, analytical penetration, high personal initiative, high resilience, and flexibility
  • Willingness to undertake worldwide business trips (max. 10%)

  • Senior Regulatory Affairs Manager

    vor 1 Monat

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    Senior 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...

  • Regulatory Affairs Spezialist

    vor 1 Woche

    Erlangen, Bayern, Deutschland HumanOptics Holding AG Vollzeit

    StellenbeschreibungRollenprofilWir suchen als innovativer und international ausgerichteter Hersteller von Premium-Implantaten für die Augenchirurgie einen Regulatory Affairs Spezialist (m/w/d) zur Verstärkung unseres Teams am Standort Erlangen. Als Experte für Medizinprodukte-Regulierung werden Sie an der Pflege und Mitarbeit bei der Erstellung von...

  • Regulatory Affairs

    vor 1 Monat

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    Deine Rolle:Wir suchen eine motivierte Werkstudentin (w/m/d) für unseren Bereich Regulatory Affairs / Qualitätsmanagement. In dieser Position wirst du Teil unseres globalen Teams und unterstützt uns bei der Pflege von Arbeitsanweisungen, der Erstellung und Anpassung von Präsentationen sowie der Pflege von Intranet- und SharePoint-Seiten.Deine Aufgaben:...

  • Senior Regulatory Affairs Manager

    vor 4 Wochen

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    At 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...

  • Regulatory Affairs Specialist

    vor 1 Monat

    Erlangen, Bayern, Deutschland HumanOptics Holding AG Vollzeit

    JobbeschreibungWir 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...

  • Regulatory Affairs Specialist

    vor 4 Wochen

    Erlangen, Bayern, Deutschland HumanOptics Holding AG Vollzeit

    Als innovativer und international ausgerichteter Hersteller von Premium-Implantaten für die Augenchirurgie suchen wir zum nächstmöglichen Zeitpunkt in Vollzeit einen Regulatory Affairs Specialist (m/w/d) für unsere Niederlassung in Erlangen.Regulatory Affairs Specialist (m/w/d)HauptraumZulassung und Registrierung von Medizinprodukten in nationalen und...

  • Digital Transformation Leader for Product Information Management

    vor 2 Wochen

    Erlangen, Bayern, Deutschland Siemens Energy Vollzeit

    About the RoleAs a Digital Transformation Leader for Product Information Management, you will be responsible for overseeing and managing a team of solution architects and PLM domain experts within the area of Product Information management. Your focus will be to ensure cross-service collaboration to shape one joint team who drives design and implementation...

  • Senior Manager

    vor 4 Wochen

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    Do you want to shape the future of healthcare? Our company, Siemens Healthineers, is a leading global medical technology company dedicated to creating innovative technologies and services. We are looking for a Senior Manager to join our team and contribute to our mission.We offer a dynamic and flexible environment with opportunities to grow personally and...

  • Chief Digital Solutions Architect for Global Engineering

    vor 1 Woche

    Erlangen, Bayern, Deutschland Siemens Energy Vollzeit

    About the RoleAs a Chief Digital Solutions Architect for Global Engineering at Siemens Energy, you will play a pivotal role in driving innovation and strategic growth. You will lead cross-functional teams to develop and implement cutting-edge digital solutions that transform the way our engineering processes operate.Key Responsibilities:Lead the design,...

  • Cyber Security Expert: Defending Healthcare's Digital Future

    vor 1 Woche

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    About Siemens HealthineersAs a leading global medical technology company, we are driven to shape the future of healthcare. With over 71,000 dedicated colleagues in more than 75 countries, we strive to make a meaningful impact on people's lives.Your Role: Cyber Security ExpertWe are seeking an experienced Cyber Security Expert to join our team and help...

  • Sales Financing Expert for Healthcare Innovations

    vor 1 Woche

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    About Siemens HealthineersSiemens Healthineers is a leading medical technology company with a global presence in over 75 countries. Our team of 71,000 dedicated colleagues is committed to shaping the future of healthcare.Role OverviewWe are seeking an experienced Sales Financing Expert to join our team in Central and Western Europe (CWE) and Nordic countries...

  • Senior Manager

    vor 4 Wochen

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    Are you passionate about shaping the future of healthcare? Siemens Healthineers is a leading global medical technology company, and we're looking for a Senior Manager to join our team.As a Senior Manager, you will be responsible for developing and implementing our standardization strategy for global market access. You will work closely with our business...

  • Datenmanager (m/w/d) - Experte für Energieübertragung

    vor 4 Wochen

    Erlangen, Bayern, Deutschland experts for professionals Vollzeit

    Experten für Energieübertragung gesuchtWir suchen einen erfahrenen Datenmanager (m/w/d) für unser Team in Erlangen. Als Experte für Energieübertragung werden Sie sich mit der Verwaltung und Weiterentwicklung eines Digital-Twins einer Hochspannungs-Energieübertragungsanlage beschäftigen. Ihre Aufgaben umfassen die Digitalisierung von Designwerten und...

  • Cost Management Expert for Construction and Engineering

    vor 1 Tag

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    Company OverviewSiemens Healthineers is a leading global medical technology company, with 71,000 dedicated colleagues in over 75 countries. Our innovative technologies and services benefit an estimated 5 million patients worldwide every day.About the RoleWe are seeking a Cost Management Expert to join our team, responsible for preparing and maintaining...

  • Digitalization Expert for Manufacturing Execution Systems

    vor 4 Wochen

    Erlangen, Bayern, Deutschland Siemens Energy Vollzeit

    Job Title: Digitalization Expert for Manufacturing Execution SystemsAbout the Role:As a Digitalization Expert for Manufacturing Execution Systems at Siemens Energy, you will be responsible for overseeing the development and implementation of MES solutions to enhance operational efficiency and meet business objectives. Your day will start with meetings to...

  • Digital Communications Strategist for Global Procurement

    vor 2 Wochen

    Erlangen, Bayern, Deutschland I. K. Hofmann Vollzeit

    We are seeking a skilled Digital Communications Strategist to join our team at I. K. Hofmann in Erlangen, Germany.About the RoleThis is an exciting opportunity to support the Transformation & Change Management department in promoting awareness, communication, and engagement within the Procurement community.Develop and implement effective digital...

  • Digital PLM Solution Architect

    vor 4 Wochen

    Erlangen, Bayern, Deutschland Siemens Energy Vollzeit

    About the RoleAs a seasoned IT Manager, you will oversee and manage a team of solution architects and PLM domain experts within the area of Product Information management. Your focus will be to ensure cross-service collaboration to shape one joint team that drives design and implementing business requirements along our PLM journey. You will support the...

  • Digital PLM Solution Architect

    vor 4 Wochen

    Erlangen, Bayern, Deutschland Siemens Energy Vollzeit

    IT Manager for PLM Solution DesignAbout the RoleAs an IT Manager for PLM Solution Design, you will oversee and manage a team of solution architects and PLM domain experts within the area of Product Information management. Your focus will be to ensure cross-service collaboration to shape one joint team that drives design and implementing business requirements...

  • IT Manager for PLM Model Based Design Expert

    vor 4 Wochen

    Erlangen, Bayern, Deutschland Siemens Energy Vollzeit

    IT Manager for PLM Model Based Design ExpertAbout the RoleAs an IT Manager for PLM Model Based Design, you will be responsible for coordinating and managing a global team of experts with cross-functional expertise. Your role involves running projects for a global 3D CAD platform on NX integrated with Teamcenter. You will also be responsible for providing...

  • Cyber Security Expert

    vor 4 Wochen

    Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

    Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.We offer you a flexible and dynamic environment with opportunities...