פורום מנהלי הייטק

• 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
• 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.)

אזור:באר שבע\עומר

אימייל לשליחת קורות חיים:biotech.isr@gmail.com