We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sounds interesting?

Then come and join our global team as Teamlead Regulatory Affairs - Global Market Access (f/m/d) Software as a Medical Device.

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.

Even more flexibility? Mobile working from abroad is possible for up to 30 days a year under certain conditions and in selected countries.

This position is full-time or part-time with a minimum of 28h/week.

Please submit your complete application documents (CV + cover letter).

Your tasks and responsibilities:

• You lead the international Regulatory Affairs team with a focus on global market access and drive its continuous development.
• You coordinate the analysis of country-specific regulatory requirements and derive appropriate market access strategies.
• You ensure global compliance by collaborating independently with country organizations, Corporate Regulatory Affairs, and various functions within the Digital & Automation Business Line.
• You manage regulatory projects (e.g., implementation of new requirements such as MDR) and drive strategic adaptations to ensure faster market entry.
• You ensure continuous and timely market access in all international markets, supporting a smooth sales start after product launch.
• You are responsible for the approval of new products, assess risks to existing approvals, and communicate these clearly and purposefully.
• You prepare comprehensive status updates and decision-making materials for the Digital & Automation management team.

To find out more about the specific business, have a look at Digital Solutions & Automation.

Your qualifications and experience:

• You hold a university degree in law, medicine, engineering, or another relevant scientific discipline.
• You bring many years of professional experience in the healthcare sector or a related environment.
• You are highly familiar with regulatory frameworks such as MDR, ISO 13485, and QSR.
• You have in-depth knowledge of international approval processes and market access strategies.
• You also bring proven experience in functional leadership, e.g., through leading project teams or coordinating specialist work packages.

Your attributes and skills:

• Your profile is complemented by excellent verbal and written English skills.
• You communicate clearly, persuasively, and in a target‑group‑oriented manner - both internally and externally.
• You lead and motivate your team confidently and foster a professional, collaborative work environment.
• You work in a structured, strategic, and solution‑oriented manner and maintain an overview even in complex situations.
• You act proactively and independently, drive topics forward, and ensure continuous development.
• You combine resilience with sound decision-making and remain focused and reliable under time pressure.

Our global team:

Siemens Healthineers is a leading global medical technology company. 74,000 dedicated colleagues in over 70 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.#myabilityshs

Wish to find out more before applying? Contact us: recruitinggersupport.func@siemens-healthineers.com, if you wish to discuss any initial questions with our recruitment team. The contact person handling this job ad is Antonia Hanke.

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Click here to get started.

To all recruitment agencies:

Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated.