Rob Fritzenkotter
Senior Consultant @Biomedix Regulatory Consulting
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WORK HISTORY
Senior Consultant @Biomedix Regulatory Consulting
San Diego County, CA, US
Regulatory Affairs Practice and Services-Support the development of US FDA 510(k), De Novo, and PMAs submissions-Support life cycle management of EU Tech Files, NDAs, ANDAs and DMFs including submission of amendments, supplements, annual reports, and other regulatory documents. https://bcert.me/seyxmskwo-Provide consulting services including regulatory strategy and quality support related to device as well as drug device combinations-Perform due diligence audits of applications in association with the buying or selling of pharmaceutical and medical device companies-Prepare FDA meeting requests and requisite briefing packages for PDUFA and GDUFA meetings and support with FDA meetings.
EDUCATION
San Diego State University
Bachelor of Science in Applied Arts and Sciences, Biology
ABOUT ROB FRITZENKOTTER
Rob is a Quality System and Regulatory professional with over 20 years of experience in QMS development, deployment, and remediation in the medical device industry. His experience encompasses all components of developing and maintaining quality systems compliant with FDA 820, EU MDR, MDSAP, ISO 13485:2016, and ISO 9001:2015 regulatory requirements, including organizational goals, standardized practices, documentation, personnel training, audit preparation and remediation. He possesses exceptional interpersonal, presentation, and communication skills that facilitate effective interaction with personnel at all levels of an organization, from line workers to executive management.
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