Head (f/m/d) of Regulatory and Clinical Affairs for Software as a Medical Device (SaMD)

Then come and join our global team as Head (f/m/d) of Regulatory and Clinical Affairs for Software as a Medical Device (SaMD).

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 full-time or part-time with a minimum of 30h/week.

Your tasks and responsibilities:

• You will be the disciplinary leader of a small team consisting of Team Leads and Direct Reports for the areas of "Product Strategy" and "Global Market Access" in Regulatory and Clinical Affairs at our sites in Forchheim and Erlangen
• Together with the team leaders you will define the strategic direction of the Regulatory and Clinical teams and ensure an adequate level of knowledge and further development of the employees
• You will define the global regulatory strategy for the D&A product portfolio and be responsible for its implementation at all D&A sites (China, Germany, India, USA)
• You are responsible for defining an efficient Regulatory and Clinical Affairs process, including its interfaces e.g. to Product Lifecycle Management - You initiate digitalization projects to automate process steps
• You manage employees at all levels with regard to regulatory compliance as a prerequisite for legal market access worldwide
• You will work closely with the international departments at D&A and the regional Siemens Healthineers country organizations to coordinate regulatory activities and also manage cross-business unit regulatory activities
• You will coordinate regulatory approvals of D&A software worldwide, especially for the EU, China and the US. In case of critical issues, you will independently conduct negotiations with authorities and other external institutions (e.g. "Notified Bodies")
• You will drive Siemens Healthineers-wide technical teams to achieve coordinated, application-appropriate implementations of country requirements for the business areas

To find out more about the specific business, have a look at https://www.siemens-healthineers.com/de/products-services 

Your qualifications and experience:

• You have a university degree in the field of medical technology, technical communications, law, computer science, or equivalent
• You have many years of professional experience in quality management and/or product approval in the medical technology or pharmaceutical environment
• You already have many years of professional experience and further qualifications in this field, but no university degree? Then we are also looking forward to your application
• You have several years of experience in personnel management and in working in multi-national teams
• Ideally, you have already had contact with the design and execution of clinical studies
• You have very good knowledge in the area of medical software applications (SaMD), and ideally in the clinical area of radiology
• You can demonstrate very good knowledge of standards (ISO13485, ISO14971) and regulatory requirements (e.g. EU MDR/IVDR, Canadian MDR, US FDA 21 CFR), especially regarding qualification and classification of medical devices

Your attributes and skills:

• With your very good written English skills, you can understand technical documentation (product specifications, risk analyses, etc.) and derive content for regulatory documents from it
• Your very good oral English skills enable you to act confidently at all organizational levels internally as well as externally towards representatives of authorities
• Your excellent communication, networking and moderation skills allow you to communicate confidently with internal and external interfaces
• Personally, you are characterized by an analytical mindset, a strong focus on results, excellent assertiveness, initiative, and the ability to understand complex technical and process-related interrelationships
• You take initiative, independently assess opportunities and risks, set ambitious goals, and motivate employees regarding the implementation of such goals