ABOUT ME

I am a Regulatory Affairs and Quality Management Consultant with more than 10 years’ experience in the medical device industry, including IVDs. I am passionate about medical device innovation and am excited to live in Silicon Valley where medical device technology is cutting-edge. With hands-on experience in the design control process, including both domestic and international regulatory submission experience, I understand what it takes to bring these devices from concept to reality and very much enjoy the challenges involved in compiling and narrating the documents necessary to support a successful filing.

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Certified as an ISO Lead Auditor, I am committed to Regulatory Compliance and understand what it takes to build and maintain a strong Quality System, a key element in bringing good quality medical device products to the market in a safe and expedient fashion. I have expertise in developing, streamlining and updating Quality Management Systems (QMS) for medical devices, in compliance with ISO 13485 and cGMP / FDA requirements. I have significant experience in both ISO audits and FDA inspections and am knowledgeable in how to prepare the appropriate response to deficiencies observed and documented.

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As a Regulatory Compliance Consultant, I understand what it takes to work within a budget and to a schedule. I am a strong communicator who is project driven and detailed oriented. I work well both one-on-one and with cross-functional project teams. I look forward to working with you and your company to achieve your goals.

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