Who We Are
Paragon Vision Sciences, Inc., a Cooper Vision specialty eye care company, is a world leading manufacturer of specialty contact lenses and oxygen permeable contact lens materials. Our CRT® lens (a class three medical device) is considered the lens of choice by many eye care professionals around the world. Paragon’s office is located in Gilbert, Arizona.
Why Work With Us
We are certified as a Great Place to Work! Our environment recognizes each employee as a vital member of the team. Integrity and respect are fundamental to our working relationships. We are friendly, inventive, and dedicated. We don’t quit until the job is done right! Our lenses don’t just change vision, they change lives. Join a team that is passionate about improving other’s visual health and quality of life.
The Manager of Regulatory Affairs and Quality Assurance, for Paragon Vision Sciences, is a hands-on position, responsible for the development, implementation, and maintenance of the applicable regulatory and quality system requirements. The Manager of RAQA will ensure compliant design, manufacturing, and distribution processes according to 13485:2016, 21 CFR 820, and other quality system requirements. The Manager 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 Manager role is accountable and given the authority to manage, resource, and guide the RAQA organization.
KNOWLEDGE, SKILLS AND ABILITIES