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vor 1 Woche
We are seeking a highly skilled Senior Regulatory Affairs Manager to join our team at Siemens Healthineers AG. As a key member of our global regulatory affairs team, you will play a critical role in ensuring compliance with international regulatory requirements for in-vivo medical devices and in-vitro diagnostic products.
Key Responsibilities- Provide active and practical support to our manufacturing units and countries in the analysis and implementation of international regulatory requirements.
- Communicate new or changed regulatory requirements to the global Regulatory Affairs Community of Siemens Healthineers and lead international Regulatory Affairs expert teams/task force teams to achieve practical and legally compliant solutions.
- Independently advise employees on achieving and maintaining legal compliance as a prerequisite for global market access for in-vivo and in-vitro diagnostic medical devices.
- Develop new and future-oriented strategies for digitalization of processes in particular in the area of Regulatory Affairs and Technical Standards with focus on Market Access and Regulatory Compliance intended to improve market access and maintenance of market access.
- Contribute to the identification of new digital transformation opportunities in Regulatory Affairs and create impact by implementing those opportunities in respective projects.
- Bachelor's degree in natural sciences or engineering; alternatively, a degree in Regulatory Affairs for medical devices.
- Several years of substantial relevant professional experience in the field of Regulatory Affairs for in-vivo and/or in-vitro products.
- Experience in AI/LLM applications and digital solutions within Regulatory Affairs Processes.
- Familiarity with the global regulatory requirements for in-vivo and/or in-vitro products and good regulatory knowledge of the European Medical Device Directives and the European Medical Device Regulations and 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.
- Practical experience in globally acting matrix organizations leading projects and interdisciplinary cross-functional global project teams.
- 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 and manage them.
- Entrepreneurial thinking and action, strong motivational ability, analytical penetration, high personal initiative, as well as high resilience and flexibility.
- Willingness to undertake worldwide business trips (max. 10%).
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