QA / RA Director

Mandatory:
• 7+ years of experience in QA/RA positions.
• Solid understanding and proven of ISO 13485, 21 CFR 820 QSR, ISO 14971..
• Proven experience with regulatory submissions including FDA and obtaining regulatory approvals/clearances.
• Verbal and technical writing skills.
Advantageous:
• Familiar with MDR requirements.
• Qualification and experience as an internal auditor
• Experience and understanding of IEC 60601, IEC 62304 and software development lifecycle.
Education:
• Bachelors Degree required (preferably in a engineering or bilogical field) or equivalent in work experience.
Required Skills, Knowledge and Characteristics:
• Highly motivated, committed and responsible.