• Regulatory Affairs/Quality professional (pharmaceuticals, medical devices, and biological products) with >20 years experience. Areas of expertise include regulatory strategy and Agency/Notified Body interactions, global submissions, risk assessment and mitigation, auditing, contract outsourcing, quality systems, validation (facility, systems, product, process and software), adverse event/medical device reporting, and pre-clinical (GLP) studies.
• Product experience includes biologics/bio-pharmaceuticals, implantable devices, conventional dose and transdermal pharmaceutical products, hand sanitizers, manual and electronic stethoscopes, combination products, medical tapes, electrosurgical accessories, ECG monitors, ECG cables and leads, X-ray CT scanners, intra-oral dental scanners, medical imaging software, PACS and MDDS systems, dental restorative products, and surgical masks.
• Certified Regulatory Affairs Professional (RAC); member of the Regulatory Affairs Professionals Society (RAPS).
• MBA with major concentration in Finance, minor concentration in Operations Management.
• Direct supervisory experience.