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 to go beyond your comfort zone in order to grow personally and professionally. Sound interesting?
Then come and join our team as Senior Regulatory Affairs Manager (f/m/d) with Focus on Digitalization to support our Business Areas, Business Lines, Business Horizontals and Technology Units in close cooperation with our country organizations in the procurement, analysis and application-oriented interpretation of international laws, regulations and guidelines regarding in-vivo medical devices and in-vitro diagnostic products.
Choose the best place for your work - Within the scope of this position, it is possible, in consultation with your manager, to work mobile (within Germany) up to an average volume of 60% of the respective working hours.
Your tasks and responsibilities:
You are responsible for active and practical support of our manufacturing units and countries in the analysis and implementation of international regulatory requirements and act as the central contact person
You communicate new or changed regulatory requirements to the global Regulatory Affairs Community of Siemens Healthineers and take the lead in and/or participate in international Regulatory Affairs expert teams / task force teams to achieve practical and legally compliant solutions
You independently advise our employees on achieving and maintaining legal compliance as a prerequisite for global market access for in-vivo and in-vitro diagnostic medical devices
You are responsible to 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
You will contribute on identification of new digital transformation opportunities in Regulatory Affairs and you create impact by implementing those opportunities in respective projects
To find out more about the specific business, have a look at https://www.siemens-healthineers.com/products-services
Your qualifications and experience:
You have a degree in natural sciences or engineering; alternatively, you have 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 are familiar with the 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
Your attributes and skills:
You can demonstrate your strong communication skills with your 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 (entrepreneurship), strong motivational ability, analytical penetration, high personal initiative, as well as high resilience and flexibility
In addition, you are willing to undertake worldwide business trips (max. 10%)
Our team
Siemens Healthineers is a leading global medical technology company. 71,000 dedicated colleagues in over 75 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.
Our culture:
Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success.
Check our Careers Site at https://www.siemens-healthineers.com/de/careers
As an equal opportunity employer, we welcome applications from individuals with disabilities.
Wish to find out more before applying? Contact us: +49 (9131) / 17 - 1717, if you wish to discuss any initial questions with our recruitment team. The contact person handling this job ad is
Simone Morgenstern.
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Siemens Healthineers Germany was awarded the Great Place to Work® certificate.
