Beschreibung
Task:- 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 (Must have):
- 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
- Fluent english
Environment/Miscellaneous:
Full-Time
Beginn: 03.02.2014
Dauer: 31.12.2014
Branche: Medizin/Healthcare