Judy Brimacombe

Judy Brimacombe has extensive work experience in the medical device industry. Judy currently serves as the Vice President of Quality & Regulatory at XII Medical since November 2021. Previously, they held the role of Vice President of Quality, Clinical & Regulatory Affairs at DawnLight from May 2020 to October 2021.

Before that, Judy worked at Earlens Corporation, a Silicon Valley start-up in hearing healthcare. In their position as Vice President of Quality, Clinical & Regulatory Affairs from February 2016 to March 2020, they played a crucial role in supporting the commercialization of a novel hearing aid. Their responsibilities included obtaining FDA clearance for the company's de novo premarket notification and managing the final report and closure of the IDE for a pivotal FDA clinical trial.

Judy also has experience at ZEISS Medical Technology, where they worked as the Director of Clinical & Regulatory Affairs from June 2003 to February 2016. During their time there, they established a clinical and regulatory affairs division and initiated a clinical trial for a newly acquired excimer laser used in LASIK surgery. Additionally, they built the division within a company that historically focused on Class I products but was expanding into manufacturing Class II devices.

Prior to ZEISS Medical Technology, Judy served as the Senior Director of Clinical & Customer Service at Advanced Bionics from November 1998 to September 2002. Judy led the company's service organization and played a key role in rebuilding the customer service department. Judy hired, trained, and motivated personnel and created two new divisions for data management and sales administration, resulting in improved customer databases and sales tracking systems.

Judy's early career involved working at Cochlear, a North American subsidiary office of Cochlear Limited, from October 1984 to 1998. There, they held the position of Vice President of Quality, Clinical & Regulatory Affairs and contributed to the regulatory approval process, compliance programs, and FDA panel meetings for new product approvals and indications for device use.

Overall, Judy Brimacombe has a track record of leadership and expertise in quality, clinical, and regulatory affairs within the medical device industry.

Judy Brimacombe pursued their education in a chronological manner. Judy obtained a Bachelor's degree in Communication Sciences and Disorders, General from Western Washington University, where they attended from 1972 to 1977. Later, they pursued further studies and achieved a Master's degree in Hearing Science from UC Santa Barbara, from 1979 to 1981.