Senior Regulatory Affairs Manager
vor 4 Wochen
Are 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 standards.
Your Key Responsibilities:- Provide expert guidance on international regulatory requirements and act as a central contact point for our manufacturing units and countries.
- Communicate new or changed regulatory requirements to the global Regulatory Affairs Community and lead international Regulatory Affairs expert teams to achieve practical and legally compliant solutions.
- Independently 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 in Regulatory Affairs and Technical Standards, focusing on Market Access and Regulatory Compliance to improve market access and maintenance.
- Contribute to identifying new digital transformation opportunities in Regulatory Affairs and implement those opportunities in respective projects.
- You hold a degree in natural sciences or engineering, or a degree in Regulatory Affairs for medical devices.
- You have several years of substantial relevant professional experience in the field of Regulatory Affairs for in-vivo and/or in-vitro products.
- You have experience in AI/LLM applications and digital solutions within Regulatory Affairs Processes.
- You're familiar with global regulatory requirements for in-vivo and/or in-vitro products and have good regulatory knowledge of the European Medical Device Directives and the European Medical Device Regulations and international medical device standards.
- You have 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.
- You have practical experience in globally acting matrix organizations leading projects and interdisciplinary cross-functional global project teams.
- You demonstrate strong communication skills with negotiation-level English language skills in speaking and writing; German language skills are an advantage.
- You have an independent, structured, goal-oriented working style, are assertive, and know how to use your intercultural experience to interact with different cultures and personalities in international teams and manage them.
- Your personal strengths include entrepreneurial thinking and action, strong motivational ability, analytical penetration, high personal initiative, as well as high resilience and flexibility.
- You're willing to undertake worldwide business trips (max. 10%).
At Siemens Healthineers, we're committed to creating a diverse and inclusive work environment where everyone feels valued and empowered to contribute their best. If you're passionate about shaping the future of healthcare and have the skills and experience we're looking for, we encourage you to apply for this exciting opportunity.
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