RA specialist

Assembly of technical files and regulatory clearance submissions, including US, PMDA, Brazil, Korea, China, etc.
Working with QA, R&D and Operations to obtain appropriate documents.
Minimum requirements:
• B.Sc. or M.Sc. in Engineering/ biomedical engineering or Life Sciences
• At least 1-3 years of experience with Class II Medical Devices and different regulatory systems
• Working knowledge of ISO standards, Submissions: 510k’s, CE, Technical Files, STED
• Preferred requirements:
• Technical orientation