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 global team as Senior Regulatory Affairs Manager (f/m/d) to help shape the strategy for regulatory approvals of software medical devices at D&A.

　　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 will be responsible for analysing and interpreting international laws, regulations and standards for medical device manufacturers and you will coordinate with your colleagues regarding the regulatory requirements for D&A products

　　You will be responsible for global approval requirements and developing the approval strategy for new products and new product versions. To this end, you will coordinate employees at all levels with regard to legal compliance as a prerequisite for legal market access worldwide

　　You will ensure close cooperation with the international specialist departments at D&A and the regional Healthineers country organisations to coordinate approval activities

　　You will be responsible for the documentation for official approvals of D&A software worldwide, in particular for China and the USA

　　In the event of critical issues, you will be responsible for negotiations with authorities and other external institutions

　　You will drive the work in Healthineers-wide specialist teams to achieve coordinated, application-orientated implementation of country requirements for the business areas

　　To find out more about the specific business, have a look at Imaging IT. (https://www.siemens-healthineers.com/medical-imaging-it)

　　Your qualifications and experience:

　　You have a degree in medical technology, (technical) communication, law, natural sciences or a comparable degree

　　You have long-term professional experience in quality management or process management in the medical technology or pharmaceutical environment

　　You can demonstrate very good knowledge of standards (ISO13485, ISO14971) and legal requirements (e.g. German MPG, EU MDR/IVDR, Canadian MDR, US FDA), especially with regard to qualification and classification of products

　　You have demonstrable knowledge of radiological systems and their software applications

　　Your attributes and skills:

　　With your knowledge of English, you can understand technical documentation (product specifications, risk analyses, etc.) and derive content for approval documents from it. Knowledge of German is an additional plus

　　With your good communication, networking and moderation skills, you communicate confidently with internal interfaces as well as externally with representatives of the authorities

　　Personally, you are characterised by an analytical mindset, a strong focus on results, very good assertiveness, initiative and the ability to understand complex technical and procedural contexts

　　Our global 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

　　Katharina Tostmann.

　　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 (https://talent.siemens.com/stayconnected) to get started.

　　Siemens Healthineers Germany was awarded the Great Place to Work® certificate.