Business
Bluejay Diagnostics Appoints Edwin Rule as Vice President, Regulatory, Quality and Compliance
ACTON, Mass., March 28, 2022 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay”, “the Company”) a late-stage, pre-revenue diagnostics
About this update from Bluejay Diagnostics, Inc.
[{"type":"text","content":"ACTON, Mass., March 28, 2022 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay”, “the Company”) a late-stage, pre-revenue diagnostics company focused on developing cost-effective, rapid, near-patient products for triage and monitoring of disease progression, today announced that Edwin “Ed” E. Rule, has joined the Company as Vice President Regulatory, Quality and Compliance. He will report to Neil Dey, Chief Executive Officer. Mr. Rule is a highly credentialed regulatory, quality and compliance professional with more than 15 years of industry experience. He has extensive training and expertise in medical device regulations in the U.S. and numerous international markets. In addition, he brings vast experience in FDA medical device submissions, Quality/Regulatory requirements for documentation, records and process qualification and Quality System Auditing. Mr. Rule also brings a track record in developing and implementing quality systems, building bridges to effectively work with the FDA and other regulatory agencies and leading high-performance teams. Most recently, he was Director, Regulatory Affairs, Devices, for a well-known, respected medical device manufacturer. Mr. Rule will be responsible for Bluejay’s Regulatory, Quality and Compliance functions and will provide support to the Symphony System product development team. “I am very pleased to welcome Ed to Bluejay. This is a very important time for the Company, as we work to complete our product development program and submit a marketing application for our first product candidate, the Symphony IL-6 Test, to the FDA later this year. Ed’s vast experience in regulatory affairs, quality and compliance will be instrumental to building highly effective, high-caliber systems to advance the Symphony IL-6 Test and upcoming programs in the pipeline through the regulatory process and preparation for commercial launch,” said Neil Dey, Bluejay’s Chief Executive Officer. Edwin Rule, Vice President of Regulatory, Quality and Compliance of Bluejay Diagnostics, said, “I have dedicated my career to helping to bring important, new medical devices to patients by developing constructive regulatory strategies and quality systems to ensure the production of high quality, compliant products. I have done this by working closely with cross-functional teams and forging effective r...