Beschreibung
Principal Consultant - SeniorTasks:
* Conception and Implementation of a „Software as a Medical Device (SaMD)" Framework
* Consulting on regulatory requirements, when implementing SaMD projects (standards, security and privacy requirements etc.)
* Consulting on accreditation of SaMD projects
* Review of SaMD project specific deliverables from a regulatory and formal perspective
Requirements:
* Strong analytical skills
* Strong negotiation skills
* Strong expertise in building Quality management system frameworks
* Strong expertise in IEC 623366, IEC 60601, IEC 80001, ISO 13485
* Teamplayer
* Fluent english
Non-Technical profile requirements
* Accepts personal responsibility for client satisfaction
* Strong tracking, coordination and project planning skills
* Establishes and manages engagement objectives, expectations and quality plan
* Ability to identify and implement process and/or application improvements
* Strong analytical and problem-solving skills
* Must be able to work on multiple simultaneous tasks with limited supervision
* Quick learner, motivated self-starter
* Excellent customer service, interpersonal, communication and team collaboration skills
* Able to follow change management procedures and internal guidelines Methodology/Certification requirements
* Master and/or Bachelor Degree in Mathematics, Engineering, Computer Science, Chemistry or Bioinformatics OR equivalent through experience. Advanced course work in technical systems plus continued education in technical disciplines is preferred
* Additional certification is a plus Language proficiencies
* English spoken and written
* German spoken and written
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