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 Head (f/m/d) of Regulatory Affairs for IVDs in Marburg to ensure the high quality of our products for our customers. 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). Your tasks and responsibilities: As Head of the Regulatory Affairs department in Marburg you are responsible for the global registration for all brands and countries for hematology, hemostasis, and plasma protein IVD products. The department consists of Regulatory Affairs Group Leaders covering new products, commercial products, and international supported by Regulatory Specialists in each area. In addition, this department manages regulatory projects, for example IVDR, EUASIA and others as required by the regulatory environment You will be responsible for 25 employees and will have 5 direct (international) reports. This position reports to the Global Laboratory Diagnostics (LD) RA Head in the USA and reports in country to the local Quality Head You are responsible to ensure continued and timely market access for all US and international markets after product development to allow immediate sales after product launch and ensure uninterrupted supplies and business. You supervise the initial approval of new products and assess and communicate the risk involved for the maintenance of existing approvals (e.g., re-registrations in key markets). A key aspect of the position is the contribution to a “faster time to market” strategy Furthermore, you are responsibly for monitoring the changes in US and international regulations and guidelines pertaining to Marburg product lines, interpreting new requirements, and implement / initiate implementations of changes together with relevant departments within LD Marburg You give monthly updates to the Marburg Quality Head as well as to the quarterly and annual Management Review You will be lobbying through collaboration in working groups of industry associations, e.g., AdvaMed on behalf of Marburg in alignment with Global LD RA and providing input to the representatives attending the AdvaMed Board and teams You are responsible for the FDA collaboration on behalf of Marburg RA for IVD submissions, and align on programs and guidance with Global LD RA You are fully responsible to build and maintain close relationships to Health Authorities, e.g., FDA, Notified Bodies, and external organizations with the goal of transparent requirements and a building cooperation To find out more about the specific business, have a look at Laboratory Diagnostics Your qualifications and experience: You hold an academic degree (e.g., Bachelor of Science) and have at least 10 years of RA work experience You have at least 8 years of professional experience in Healthcare or a directly related field and related management experience You have an extensive theoretical and practical expertise in regulatory affairs including IVDs and medical devices. Furthermore, you have a strong knowledge of analyzers, workflow and solution products and applicable regulations for such products You are experienced in working with the FDA and other regulatory agencies You are an expert of common regulatory frameworks (e.g., IVDR [EU Regulation 2017/746], ISO 13485, QSR) You have knowledge in the operation of Regulatory Information Systems (RIM) You have at least 3 years of experience in successfully managing complex projects/teams You have already successfully led and motivated people and teams and you are experienced in managing group leaders as well as multi-culture, multi-site, and multi-functional teams Your attributes and skills: In this position you will have to resolve situations that are different from those you´ve encountered in the past. Thanks to your adaptability and development skills, this is not a problem for you As a leader and team player you show an effective and professional communication style, you know/use motivation techniques and you know how to handle conflicts You are enthusiastic about your work, encourage others and cope well with pressure Moreover, you demonstrate high professional judgement, and you are an idea generator for new and practical solutions You share knowledge proactively and systematically within assigned organizational units to expand the knowledge base and support a learning organization You have excellent coordination as well as strategic planning skills In discussions with regulatory authorities, you show exceptionally good negotiation skills and as well as your public speaking ability Your English skills are business fluent both written and spoken (especially important for FDA contact); ideally you also have knowledge of German Our global team: Siemens Healthineers is a leading global medical technology company. 66,000 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. 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 Petra Hübener. 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. Siemens Healthineers Germany was awarded the Great Place to Work® certificate. Organization: Siemens Healthineers Company: Siemens Healthcare Diagnostics Products GmbH Experience Level: Experienced Professional Job Type: Full-time