דרושים בתחום רפואה ובריאות

The resource shall support Compliance projects in Medical Device area. The resource shall also bring new expertise in quality management and regulatory affairs for Medical Device and contribute to the growth of the Medical Device team and to enhance PQE services in Medical Device area.

JOB FUNCTIONS
Support projects for Medical Device EU and extra EU registration
Support Compliance and Quality Management System projects for Medical Device Companies
Perform audits in Medical Device area

Please send your CV in English ONLY
Degree in Technical discipline

Coordinate with Core Team and maintain/guarantee the documentation/validation strategy defined.
Support and coordinate documentation/validation and training activities with project core and site members
Managing multi-sites documentation alignment team
Coordination of validation activities and deliverables against an agreed project gantt
Ability to detect any possible issue in advance and to define possible mitigation actions per time, in collaboration with Core Team
Ability to integrate in an on-going structure, understand processes and way of work, and to teach to the team
Deliverables Creation (e.g. presentation, reports, project/validation documentation)
Resources Planning according to the agreed budget and milestones to be achieved – ability to detect budget issues per time and to document/report in adequate manner
Support authors activities planning e.g. documentation amendment, progress reporting, training, etc.
Routine and on-demand reporting to program site/core alignments
People management experience – optional

Knowledge in Documentation Life Cycle and Good Documentation Practices