Los Angeles Metropolitan Area
Results-driven professional with training and experience in the medical device industry for 8+ years. Expertise in US FDA and EU regulations, focusing on Class III/II devices. Excellent communication skills and ability to explain complex regulatory terminology to medical professionals and clients.
• Co-author EU MDR Tech Docs for Class III Transcatheter Heart Valve System. • Author FDA 5-day Notice for supplier changes. • Support IDE submission. • Review and approve Change Notices related to product manufacturing process changes, design changes, and supplier changes.
Neuromodulation Divison • Authored EU MDR Tech Docs, SSCP & GSPRs for Class III implantable, Class IIa, and Class I sterile devices. • Authored FDA Real-Time PMA Supplement for packaging/labeling changes. • Authored FDA 30-day Notice and 180-day PMA supplement for engineering/sterilization site changes. • Provided divisional feedback on Regulatory Information Management System implementation.
• Authored FDA/Health Canada Annual Reports with 200+ Change Notices. • Authored TUV Annual Review. • Authored Health Canada License Amendment for software upgrade. • Led data collection to create BUDI numbers in support of the new EU MDR Basic Unique Device Identification (BUDI) database. • Reviewed and assessed Change Notices related to product manufacturing process changes, design changes, and supplier changes. • Supported international countries (Canada, South Korea, Taiwan, Singapore, India, Turkey, South Africa, Philippines, Kazakhstan) for Neuromodulation devices registration and submission. - Vercise Deep Brain Stimulation System (Class III) - Precision Spinal Cord Stimulator System (Class III) - Superion Indirect Decompression System (Class III) - Radiofrequency Ablation System (Class II)
• Managed international product certification and registrations of Alcon NGENUITY® 3D Visualization system for medical device manufacturer. • Maintained regulatory documentation for registrations in Canada, China, Thailand, Taiwan, and Turkey. • Coordinated and participated electromagnetic compatibility (EMC) testing