Thirty years of increasing responsibility assuring compliance in the regulated medical device and pharmaceutical industries.  Strong Regulatory submission work and implementation knowledge.

Titles Held: Director of Regulatory Compliance and Quality Systems; Manager of Quality Assurance; Manager of RA/QA; Manager of Quality Control

• Successful submission of four 510(k)’s in a five-month period for Class II devices and one special
• Strong knowledge of auditing practices, regulatory and business requirements including ISO 9001, GMP’s, and international regulations
• Successfully led three organizations through the implementation process and certification process for ISO certification; led multiple organizations to certification for EN 46001:1996, ISO 13485 and EN ISO 9001
• Skilled in all aspects of a regulatory and quality management system for multiple manufacturing sites including design control
• Managed Quality System in multiple sites in the US and Puerto Rico