The Director of Regulatory Affairs and Quality Assurance, Specialty EyeCare Division is responsible for the development, implementation, and maintenance of the applicable regulatory and quality system requirements for all the Specialty EyeCare products and markets. The Director of RAQA will ensure compliant design, manufacturing, and distribution processes according to 13485:2016, 21 CFR 820, and other quality system requirements.
The Director is responsible for site and product registrations according to the applicable country/market requirements including the US, EU, China, and other markets. This position oversees RAQA resources and is responsible for establishing a state of ‘audit readiness’, in support of successful regulatory audits. The Director is the senior RAQA position in the Specialty EyeCare Division and a member of the division leadership team. The Director role is accountable and given the authority to manage, resource, and guide the RAQA organization.
KNOWLEDGE, SKILLS AND ABILITIES