Beschreibung
Administer, supervise and further development of the local technical files- Administer, supervise and further development of local tech. files, according tests and test reports & risk management documentation
- Support local product registration process
- CI of QM-Systems, especially tech. files and risk management
Background:
Experience with regulatory requirements / standards of medical device production. ISO 13485, ISO 14971, MPG, 93/42/EEC, 21CFR820)
Experience in Design control and validation, project management
Good MS Office knowledge / standard software as well very good English skills in oral and written are a must.
Good communication skills and the ability to interface with all levels of management
Able to work on own initiative and focused / good organisational skills
Good judgement and problem solving ability
Very good English and German Language Skills
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