Regulatory Affairs

A Senior Executive with diverse experience in business operations, including disposable product and electro-mechanical product manufacturing, research and development, quality assurance, and regulatory affairs. A track record of success in product development, regulatory approvals, manufacturing cost reduction and quality systems implementation.

Professional experience includes:

Director of Regulatory Affairs for a leading developer and manufacturer of hemodialysis products

VP for Quality Assurance for a startup company developing and manufacturing an extracorporeal left ventricular assist device and implantable sternal closure system

Director of Operations for a startup company that quickly became a leader in the development and manufacturing of cardiac monitoring equipment

VP of Quality Assurance and Regulatory Affairs for the country's leading developer, manufacturer and distributor of devices used in respiratory care

VP of Engineering for a leader in the development and manufacture of electro-mechanical products and equipment for physical therapy

Achievements include:

Establishing collaborative relationships with FDA resulting in successful allowance of 510(k) and IDE applications for cardiovascular support and sorbent-based hemodialysis systems

Negotiating clinical trial protocols and IDE submittals with the FDA resulting in approval to enter human clinical trials

Planning and implementing an ISO 9001, ISO 13485 and FDA QSR compliant quality system. Passing initial FDA Class III device audit with no 483 findings

Achieving CE mark recognition for products