Pam McNulty is senior-level management and quality professional with expertise in leading quality, engineering, and project/product development teams. Pam’s expertise stems from more than 25 years of experience in the medical device and microelectronics industries. As Senior Director of Quality and Compliance at Yukon Medical, she oversees the activities to maintain and enhance Quality Management System compliance with 21CFR Part 820, ISO 13485, and multiple ever-changing international regulations for vial access and IV administration medical devices. The maintenance and enhancement of the system are critical in that it provides the framework for excellent product quality and exceeding customer expectations.
Pam has led various cross-functional teams to obtain several device 510(k) clearances in the U.S., licensing in Canada, and CE Mark in the European Union, facilitating product sales in all these locations. Work is currently underway to register one of the company’s devices in 21 countries.
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