Edwin Rule

Edwin Rule

Vice President, Regulatory, Quality and Compliance

Mr. Rule joined Bluejay in 2022. Prior to this, from 2017 to 2022, he was Director, Regulatory Affairs/Devices at Fresenius Medical Care’s Renal Therapies Group. Prior to that, from 2014 to 2017, he provided medical device/pharmaceutical Quality Assurance and Regulatory Affairs consulting services to an international medical device manufacturer. Before that, from 2007 to 2014, Mr. Rule held various leadership roles in Quality/Quality Assurance at ProTom International Holding Corporation, Optos Inc., and Spire Biomedical Corporation.

Mr. Rule graduated with a Master of Science in Marketing and Technological Innovation at Worcester Polytechnic Institute. He earned a Certificate of Professional Achievement in Administration and Management from Harvard University. And he graduated with a Bachelor of Science in Mechanical Engineering from Northeastern University. Mr. Rule is an ASQ Six Sigma Green Belt and has training as an ISO 13485 Auditor. He has additional qualifications in Project and Program Management as well as FDA Clinical Trial oversight.