RAC/CQA professional with over twenty-five years experience with Medical Device Regulation in Compliance Management, Regulatory Affairs, Quality Systems and Clinical Affairs. Specializes in creative regulatory strategies to expedite product registrations.

Director of Regulatory Affairs; Corporate Director, RA/QA; Manager of Regulatory Affairs; RA/Clinical Associate

• Develop Design Control Systems and Implementation; experienced in working with product development teams to get medical devices to market in a timely manner
• Strong experience with Regulatory Compliance Programs, GMP/QSIT Audits, and Gap Analysis
• Develop and implement ISO 13485 compliant Quality Systems
• Possess extensive knowledge and expertise of FDA device regulations, EU Medical Device Directive (MDD), Notified Body Audits, FDA QSIT inspections, and IRB/IDE submissions
• International Submissions: Design Dossier and Technical File Development; Lead CE mark projects
• Extensive experience with compliance issues, Warning Letters, product recalls, facility inspections and resulting 483 responses and consent decrees

Thirty year veteran in the medical device arena, including thirteen years working for the FDA as engineer/field investigator and supervisor specializing in medical devices. Has worked with a wide range of FDA and international requirements while solving regulatory compliance issues and improving quality systems.

Titles Held: Director of Quality Assurance; Manager of Regulatory Compliance; Manager of Quality Assurance Engineering; Associate Manager of QA Engineering

• Well experienced in FDA issues including remediation of FDA-483 observations, warning letters, recalls, and consent decrees
• Has conducted medical device quality system compliance (QSR and/or ISO 13485) audits in Canada, China, Puerto Rico, Ireland, England, Germany, EU, and Mexico
• Resolved large backlog of medical device complaints, risk analysis, and investigations
• Managed remediation programs and resolved non-compliance issues leading to ISO certification and PMA & 510k approvals
• Experienced with multi-facility corporate quality assurance and regulatory compliance programs