Beschreibung
Guten Tag,I'm currently looking for a Principal Consultant - Senior (m/w) for a major player in life science based in 7*, Germany (12 months+).
Tasks:
• 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 spoken and written
• Fluent German spoken and written
Qualification Rating
ISO Regulations * Yes
QMS (Quality Management System) 4 (Very Strong) of 5 (Expert - 4+ Yrs.
Non-Technical profile requirements:
• Must be able to work on multiple simultaneous tasks with limited supervision
• 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
Please get in touch with me under or
Also, please feel free to forward this request.
Mit freundlichen Grüßen
Corinna Freier
Computer Futures
Goetheplatz 5-11
60313 Frankfurt Am Main
Germany