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 Regulatory Affairs Manager – Product Strategy (f/m/d) to shape the future of healthcare technology.

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.

Your tasks and responsibilities:

• You develop and implement regulatory strategies for software-only medical devices.  
• You serve as the primary contact for the R&D department for regulatory matters.  
• You assess product functionalities, qualify and classify devices from a regulatory perspective. 
• You take over the compilation and maintenance of technical documentation according to (EU) 2017/745 and other relevant regulations. 
• You facilitate the information exchange, provide advice, and coordinate measures with internal departments, regional units, and regulatory authorities.  
• You contribute to internal process improvement.  
• You analyze international laws and standards and coordinate regulatory compliance with colleagues from different functions. 
• You prepare and support audits conducted by notified bodies and foreign authorities. 

To find out more about the specific business, have a look at Products & Services.

Your qualifications and experience:

• You hold a university degree in medical technology, (technical) communication, law, natural sciences or a comparable field. 
• You have many years of experience in Regulatory Affairs, ideally with a focus on software-only and AI/ML-based medical devices. 
• You possess in-depth knowledge of relevant standards and regulatory frameworks such as MDR, FDA regulations, IEC 62304, ISO 14971, Good Machine Learning Practice (GMLP) and the EU AI Act.  
• You have a proven track record in managing complex, cross-functional projects, effectively collaborating with diverse teams and multiple stakeholders.

Your attributes and skills:

• You are proficient in English and able to understand complex technical documentation (product specifications, risk analyses, etc.) and translate this into clear, compliant content for regulatory submissions; German language skills are considered beneficial.
• You work in a structured and solution‑oriented manner, handling multiple regulatory topics with clarity and prioritisation.
• You demonstrate excellent communication, networking, and facilitation skills, enabling you to collaborate effectively and confidently with internal stakeholders and external partners.
• You bring strong adaptability, analytical thinking, and problem‑solving abilities, combined with a high attention to detail and strong interpersonal skills that help you navigate a dynamic environment.

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.