Senior Regulatory Affairs Manager

1 semana atrás

Porto, Porto, Portugal Siemens Healthineers Tempo inteiro

Senior Regulatory Affairs Managerin 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 ITrelated 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 nonmedical 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 crossbusiness line ITrelated 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 510 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 AIbased 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 processrelated contexts

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