Regulatory Affairs leader with 26 years of experience in medical devices. Have driven successful go to markets for a broad range of product categories (therapeutic, diagnostic, SaMD, AI/ML) through 510(k)s and De Novo pathways. Provides clear strategic leadership to business. Has managed complex external audits and remediation activities.
Key areas of expertise include:
• New Product Development
• 510(k) management
• Technical File
• European requirements
• International product registrations
• 21 CFR Part 820
• ISO 13485
• Recalls, Field Actions
• Issue Escalation / QRB
• CAPA Management
Product Experience
• Digital Therapeutics / SaMD
• Impedance plethysmographs
• Sterilization Systems, sterilants, and high level disinfectants, endoscope cleaners and reprocessors
• Dental, ophthalmic, surgical, and cosmetic laser systems.