Aktuelle Jobs im Zusammenhang mit Lead Manager of Regulatory Affairs - Erlangen, Bayern - Siemens Healthineers AG


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  • 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,...

Lead Manager of Regulatory Affairs

vor 2 Monaten


Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit

Are you ready to contribute to the advancement of healthcare? At Siemens Healthineers, we honor our dedicated professionals who bring energy and passion to this vital field. Our legacy of engineering excellence in the healthcare sector drives us forward.

We provide a flexible and dynamic workplace that encourages personal and professional growth. Interested in learning more?

Join our global team as a Lead Manager of Regulatory Affairs (f/m/d) with a Focus on Digital Transformation. You will collaborate closely with our Business Areas, Business Lines, Business Horizontals, and Technology Units, alongside our country organizations, to navigate and apply international laws, regulations, and guidelines related to in-vivo medical devices and in-vitro diagnostic products.

Work Flexibility – In this role, you may work remotely (within Germany) up to 60% of your working hours, subject to manager approval.

Your Responsibilities:

  • Provide active and practical support to our manufacturing units and countries in understanding and implementing international regulatory requirements, serving as the primary contact.
  • Communicate updates on regulatory requirements to the global Regulatory Affairs Community and lead or participate in international expert teams to develop compliant solutions.
  • Advise employees on maintaining legal compliance necessary for global market access for in-vivo and in-vitro diagnostic medical devices.
  • Develop innovative strategies for the digitalization of processes within Regulatory Affairs and Technical Standards, focusing on Market Access and Regulatory Compliance to enhance market access.
  • Identify and implement new digital transformation opportunities in Regulatory Affairs through respective projects.

Your Qualifications:

  • A degree in natural sciences or engineering, or a degree in Regulatory Affairs for medical devices.
  • Several years of relevant professional experience in Regulatory Affairs for in-vivo and/or in-vitro products.
  • Experience with AI/LLM applications and digital solutions in Regulatory Affairs processes.
  • Familiarity with global regulatory requirements for in-vivo and/or in-vitro products, including knowledge of European Medical Device Directives and Regulations.
  • Strong understanding of Quality Management systems (based on EN ISO 13485, EN ISO 9001, QSR) in process analysis and optimization.
  • Experience leading projects in globally operating matrix organizations and managing interdisciplinary cross-functional teams.

Your Skills:

  • Excellent communication skills with negotiation-level proficiency in English; German language skills are a plus.
  • Independent, structured, and goal-oriented work style, with the ability to navigate intercultural interactions effectively.
  • Personal strengths include entrepreneurial thinking, strong motivation, analytical skills, high initiative, resilience, and flexibility.
  • Willingness to travel internationally (up to 10%).

About Our Team:

Siemens Healthineers is a leading global medical technology organization. With 71,000 dedicated colleagues in over 75 countries, we are committed to shaping the future of healthcare. Millions of patients worldwide benefit daily from our innovative technologies and services across diagnostic and therapeutic imaging, laboratory diagnostics, molecular medicine, digital health, and enterprise services.

Our Culture:

We embrace diverse perspectives, open discussions, and a commitment to challenge the status quo. Change is a constant in our work, and we aspire to lead rather than react. We encourage you to take on new challenges, test your ideas, and celebrate achievements.