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 Regulatory Affairs Manager (f/m/d) Product Strategy to play a key role in the creation of the approval strategy for new AI-based medical devices and new product versions.
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.
This position is offered part-time with 20h/week.
In addition to your CV, please include a covering letter with your application.
Your tasks and responsibilities:
- You develop and implement regulatory strategies for Software as a Medical Device.
- You serve as the primary contact for our R&D department for regulatory matters.
- You assess product functionalities and product changes for our medical devices from regulatory perspective.
- You are responsible for the compilation and maintenance of technical documentation according to (EU) 2017/745 (MDR) and other relevant regulations.
- You coordinate the exchange of information with internal departments and regulatory authorities (e.g. TÜV).
- You analyze international laws and standards and coordinate regulatory compliance with colleagues from different functions.
- You contribute to our internal process improvement.
- You support the preparation of audits by notified bodies and foreign authorities and act as a technical contact person.
To find out more about the specific business, have a look at Imaging IT
Your qualifications and experience:
- You have a university degree in medical technology, (technical) communication, law, natural sciences or a related field.
- You have extensive professional experience in regulatory affairs for software as a medical device.
- You impress with your extensive experience in quality or process management in the medical technology or pharmaceutical industry.
- You also have a strong understanding of medical device clinical lifecycle management processes.
- You convince through your strong knowledge of relevant standards (e.g. ISO13485, IEC62304) and international medical device requirements.
- You have profound experience with radiological systems and their software applications.
Your attributes and skills:
- You are proficient in English, capable of understanding technical documentation (product specifications, risk analyses, etc.) and derive content for regulatory strategies. German language skills are an additional bonus.
- With your excellent communication, networking, and moderation skills, you are able to interact confidently with internal and external partners.
- Adaptability, problem-solving skills, attention to detail, analytical thinking and strong interpersonal skills complete your profile.
Our team
Siemens Healthineers is a leading global medical technology company. 72,000 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
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 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.
Siemens Healthineers Germany was awarded the Great Place to Work® certificate.
