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Shlomit Segman-Magidovich posted a job: Job position "QA and regulatory affairs A small size company in the field of home use medical devices is looking for devoted, accountable, enthusiastic and multi-tasking regulatory affairs responsible. Job description and responsibilities: • Ensure compliance with the company Quality System • Provide technical and quality support to the company. • Maintain awareness of new relevant regulatory requirements and alert staff of required system and/or procedural changes. • Preparation of regulatory and clinical documentation • Monitoring of different tests and studies such as clinical, human factors, safety, electrical standards, and chemical composition tests. Requirements: • B.Sc. in relevant fields, M.Sc. an advantage • Experience in the medical devices field; FDA, MDD and ISO 13485. • Excellent English • High-writing skills • Excellent communication skills • Project management/monitoring skills CV to Shlomit@elglobalt.com www.mysensica.com" | |||||
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