Penny has many years of experience working with regulatory affairs and quality management systems for the medical device industry. She has received two Regulatory Affairs Professional Society (RAPS) certifications (EU and US RAC). Penny is also a Certified Quality Auditor (CQA) through the American Society for Quality (ASQ).
Penny specializes in regulatory affairs submissions, FDA/ISO quality system creation and implementation, with special emphasis for ongoing facility and device compliance. Penny particularly enjoys working with product development teams to get medical devices to market in a timely manner.
Penny began her career in Medical Device Regulatory Affairs more than 25 years ago. Directly after college, she worked as an ophthalmic surgical technician for a large practice of Ophthalmologists. Later, she was employed by Ciba-Geigy (an ophthalmic medical device manufacturer) as a regulatory administrative assistant. Penny found a sense of accomplishment in the detailed work of creating regulatory strategies and maintaining legal compliance.
Penny went back to school for her paralegal degree, but continued her career in Regulatory Affairs for Medical Devices. She has regulatory, quality, and clinical experience in the ophthalmic, pediatric, cardiac, human/animal tissue, vascular access, and urological/gastroenterology medical device industries. She has worked with CR Bard, CryoLife, CIBA Vision (a Novartis company), Kimberly Clark, and many start-up life science companies.
Penny serves as the RAPS Atlanta Chapter leader. She is also an education committee member helping develop the University of Georgia’s Regulatory Affairs Program. Penny was awarded the Leonard Stauffer award from the Regulatory Affairs Professional Society in 2007. This award is given to an individual that goes above and beyond in mentoring and professional training in the regulatory field.