Holly Ramirez
Senior Principal Regulatory Affairs Specialist at Surmodics, Inc
Based in Champlin, United States
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Seniority
Director
Department
Manufacturing & Production
Location
Champlin
Industry
Medical Equipment Manufacturing
Company size
310
Contact information
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h•••••••@surmodics.com
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Background
About Holly Ramirez
Principal Regulatory Affairs Specialist with 12+ years experience in US, EU, Japan and International markets. Currently supporting Class US Combination Products including Clinical Trial Requirements, PMA Supplements and Annual Reports Extensive US 510(k) ExperienceWide-Ranging EU Experience including Design Dossier and Technical File Preparation and submission, Notified Body Transfers, and Essential Requirements ComplianceComprehensive Japan Submission Experience of Class IV devices: Submission Preparation, QMS Audits, Homework Questions, and Reimbursement StrategyWell Rounded in working in all International Regions and providing submission support
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