Twenty years of experience in the Medical Device and Biotechnology industries developing, implementing and maintaining global regulatory affairs, compliance and quality assurance strategies and systems.  Strong background with FDA Quality Systems regulations, including ISO 9000:2000, 13485:2003, CMDCAS, MDD, IVDD and HIPAA requirements.

Titles Held: Director of Regulatory Affairs/Compliance Assurance; Senior RA Specialist; Manager of Quality Assurance; Senior Quality Engineer

• ISO certification and surveillance
• State licensing and Facility registration
• QM & SOP writing; Failure investigations
• International experience: Pakistan, Costa Rica, Mexico, EU, Canada, Japan and Australia; CE Marking
• Certifications: CQA, RAC, Lead Auditor Certification