Senior Regulatory Affairs Manager
6 meses atrás
**Senior Regulatory Affairs Manager*in for Non-Product Software in a medical device environment**
Come and join our global team as Senior Regulatory Affairs Manager (f/m/d) for Non-Product Software to help shape the regulatory approval strategy for non-product software in a medical device environment at IT.
**Your tasks and responsibilities**:
- You will analyze and interpret IT-related international laws, regulations and standards and changes on them for the IT department within medical device manufacturers and independently derive the resulting regulatory requirements for IT non product software
- You independently clarify worldwide regulatory requirements and develop the regulatory strategy for new IT non-medical device products and services. To this end, you will support employees at all levels with regard to legal compliance as a prerequisite for legal market access worldwide
- You will work closely with the international departments at IT and the regional Healthineers companies to coordinate regulatory activities and manage cross-business line IT-related regulatory activities
- In case of critical issues, you will support negotiations with authorities and other external institutions
To find out more about the specific business, have a look at Siemens Healthineers IT.
**Your qualifications and experience**:
You have a degree in the field of medicine, medical technology, law, natural sciences or comparable
- You have 5-10 years of professional experience in quality management or process management and many of them in regulatory affairs 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), in particular with regard to qualification and classification of products
- Ideally, you are already very familiar with the approval of AI-based medical devices
**Your attributes and skills**:
- With your English skills you can understand technical documentation (product specifications, risk analyses, etc.) and derive content for regulatory documents from it, German language skills are an additional plus
- With your excellent communication, networking and moderation skills, you can communicate confidently with internal interfaces as well as externally with representatives of the authorities.
- Personally, you are characterized by an analytical way of thinking, a strong focus on results, very good assertiveness, initiative and the ability to understand complex technical and process-related contexts
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