Head of Regulatory Affairs Marburg

vor 1 Woche

Marburg, Deutschland Siemens Healthcare Diagnostics Products GmbH Vollzeit

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 of Regulatory Affairs Marburg (f/m/d)toensure 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 three Regulatory Affairs Group Leaders and their teams covering new products, commercial products and international areas. In addition, this department manages regulatory projects, for example IVDR, EUASIA and others as required by the regulatory environment You will be 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 will 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 will be responsible 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 Marburg You will provide monthly updates to the Marburg Quality Head and give updates 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 Regulatory Affairs Department (QT-LS RA) and provide input to the representatives attending the AdvaMed Board and teams You will be responsible for the FDA collaboration on behalf of Marburg RA for IVD submissions, and align on programs and guidance with Global QT-LS RA You will be responsible to build and maintain close relationships to Health Authorities, e.g., FDA, Notified Bodies, and external organizations with the goal of getting transparency regarding requirements and building a trustful cooperation

Your qualifications and experience:

You have an academic degree (e.g., Bachelor of Science) and have at least 10 years of working experience within RA 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 are very experienced in managing group leaders as well as multi-culture, multi-site, and multi-functional teams and you have successfully lead and motivated people and teams in the past


Your attributes and skills:

You English and German skills are business fluent both written and spoken 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 conflict 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 as well as your public speaking ability

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 atCornelia Listringhaus.

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 to get started.


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

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