SOLUTIONS
REGULATORY/CLINICAL STRATEGY EXECUTION
PEOPLE CONNECTOR
COMPLIANCE REMEDIATION
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Regulatory and clinical strategy support
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Regulatory market applications (Q-Submissions, IDE approvals, 510k, CE, product licenses/registrations)
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EU MDR registrations (technical files, CERs)
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Clinical trial support (study document/file preparation, clinical trial monitoring, training and trial administration support)
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Bringing my passion for mentoring regulatory teams to consistently and predictively achieve approvals and successful audit results
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Building partnerships between the regulator "customer" and companies to promote transparent and efficient marketing approvals
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Interim regulatory team management or support
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Lead "turnaround" QMS compliance and development of robust quality management systems (MDSAP, ISO 13485, HC, PMDA)
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Compliance / regulatory action response (FDA 483, NB Nonconformances, Warning Letter, HC Section 64 Notices)
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Partnering with the regulatory team manage communications and correspondence with regulators through execution of quality plans, audit finding responses