ביוטק

Director of RA

74030

תאריך עדכון

07/03/2016

תיאור המשרה

Qualifications:

• 10+ years of direct regulatory affairs experience within the IVD/ Medical Device industry.
• B.Sc. in Life Sciences/ Physics/ Engineering - Must, M.Sc. or Doctoral Degree preferred.
• PMA submission and /or 510(K) clearance experience with obtaining regulatory approvals for biomedical hardware and software.
• Extensive experience and understanding of ISO/FDA, QSR, IVDD, ISO 13485, ISO 15197, ISO 14971, ISO 62304, and ISO 60601 requirements.
• Lead company-sponsored interactions with regulatory bodies, especially FDA.

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