Sr. Director, Quality Assurance and Regulatory Affairs

Responsible for the site Quality system and leadership of the site Quality Assurance, Quality Control and Regulatory Affairs organization. Ensures compliance with US Federal Regulations, Regulation EU 2017/746, EN ISO 13485 standards and site Quality requirements.

Requirements

• B.S Degree or equivalent in Science or Engineering
• Minimum 10 years experience in a management capacity covering a span of responsibility within Quality Assurance and Regulatory Affairs within the IVD, Medical Device and.or biopharmaceutical industry
• Demonstrated track record in successful US FDA, EU and ROW premarket audits/inspections and regulatory submission, including 510K and IVDR/MDR
• Ability to establish processes and systems meeting Quality System Regulations (QSR), 21CFR Parts 210,211, 11, and 820, ISO 14385, ISO 14971 requirements and other related regulations with emphasis in CAPA Systems

Benefits

• Health insurance
• Retirement plan
• Stock options
• Life insurance
• Dental insurance