Clay has over 20 years experience in operations and management in the Medical Device and Tissue Bank industries. Clay co-founded and developed the Reglera division of Enscicon, and has since developed Reglera into a multi-million dollar a year business with a strong and diverse client base.
As CEO of Reglera, Clay is responsible for strategy development for Reglera. Reglera's product and services mix is a result of his experience in the Medical Device and Tissue Banking industries and reflects his vision to provide companies with solutions, not simply advice. From its launch, Clay has lead and developed the organization into one of the largest and fastest growing consulting / outsourcing companies in its marketplace. Reglera was recognized by Inc. Magazine in 2005 as #43 in the list of 100 fastest growing inner city companies in America.
Before joining Enscicon / Reglera, Clay worked for COBE Laboratories / GAMBRO Healthcare. As a part of their US Corporate Management Team, he supported GAMBRO Healthcare’s rapid growth from several hundred million to greater than $1 billion in annual revenues. Rising quickly from a top technical contributor to a position as Corporate Director of Quality Assurance, Clay’s organization led the company to establish world-class quality systems and successfully resolved chronic problems with the FDA that threatened to close the company’s US operations. Before his work at GAMBRO, Clay worked with Alcon Laboratories and helped develop and introduce two of the most successful ophthalmic surgical instruments ever brought to the market.
Whether you are developing a new product, improving an existing product, or simply trying to comply with the myriad of regulations and standards, Reglera’s products and services will accelerate your success and profitability. We accomplish this through a combination of core competencies including
Quality Systems Development
Design Control and Structured Development
Compliance Assessments and Audits
Utilizing best practices and many years of building quality and regulatory systems in regulated industries, we have developed specific consulting services and outsourcing products to help meet your regulatory requirements.
With our unique combination of regulatory expertise and operations knowledge, our teams deliver results that combine regulatory compliance and process efficiency. We do not solve your regulatory problems by installing the quality system over the top of your business system. At Reglera, we know that the most effective way to sustain business success is to combine business and quality requirements into a single, efficient system. http://www.reglera.com