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| תיאור: |
Maintain and enhance a medical device manufacturer s QA system , including hands-on preparation of new procedures
Maintain the company s preparedness for external audits at short notice
Train staff in the implementation of the company's QA procedures
Perform internal and supplier audits
Help in planning the company regulatory strategy with respect to company's new and existing products
Negotiate with all regulatory bodies and authorities: EU Notified Bodies, the Food and Drug Administration (FDA), Israeli authorities, ethical committees, etc.
Global professional responsibility for V&V processes for all the company's products
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| דרישות: |
First or second degree in QA-engineering or equivalent with bio-engineering background
Deep knowledge and familiarity with ISO quality management systems and medical device standards
Fluent spoken and written English
Ability to give talks, guide and train at all levels of the company's staff.
At least 5 years experience as a QA manager in a medical device manufacturer
Regulatory support for at least two clinical trials
Several medical device submissions to regulatory authorities (FDA, Notified Bodies, Health Canada, etc.)
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| היקף המשרה: |
מלאה |
עיר/ישוב: |
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תפקיד: |
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שנות ניסיון: |
5 שנים |
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