Advance the understanding and practice of worldwide medical Regualtory Affairs for members in the Rocky Mountain region.
Ian Marsden - President
Ian has nine years of experience in FDA regulated industry; with 3 years of experience in Regulatory Affairs, directly working on 510(k) submissions and developing regulatory strategies with a team. Ian has both a Bachelor’s of Science and a Master’s of Science in Biochemistry and Molecular Biology, as well as Chemical Engineering from Colorado State University.
Evelyn Cadman - Treasurer
Principal, FDA Compliance Simplified
Georganne Brown, RAC US, EU, Can, - Secretary
Principal Consultant, Regulatory Relief Resources, LLC.
Stacci Cronk, RAC - Program Chair
Regulatory Affairs Manager, C. R. Bard, Inc.
Stacci Cronk is Regulatory Affairs Manager with C.R. Bard, Inc. and has 10 years of experience in the drug/device industry, with 7 of those years in the Regulatory Affairs field. She has a Bachelor’s Degree in Chemistry and Mathematics from Purdue University. She received her US RAC in June 2009.
If anyone would like to join the program committee, please contact Stacci at Stacci.Cronk@CRBard.com.
Celso Duran - Social Technology Chairman
Product Associate, Regulatory Affairs, Medtronic, PLC.
Celso began working in the medical device industry in 2013. As a product associate in regulatory affairs, he is responsible for working with project teams throughout the device development process, obtaining 510(k) clearance from the FDA, preparing the MDD Technical File, and writing regulatory strategies. Celso received his Bachelor’s of Science in Bioengineering from Rice University and a Master’s of Science in Biomedical Engineering with a thesis in Tissue Engineering from Colorado State University.
Daniel Simpson, RAC (US, CAN), ASQ CBA.
Senior Direcor of Quality and Regullatory Affairs, Corgenix
Corgenix Inc. produces In Vitro Diagnostic (IVD) products for the clinical laboratory market. Mr. Simpson has a combined 24 years of experience in the human and veterinary diagnostic industry. After many years of working in the lab developing new diagnostic medical devices, he received his RAC certifications in 2008 and 2009. For the last eight years in his current role, Mr. Simpson has been in charge of Quality System Management, Regulatory Compliance, and new product submissions at Corgenix, Inc. Currently Mr. Simpson has been in charge of ensuring UDI compliance for the 28 FDA regulated products marketed by Corgenix.
Mary Armstrong - Member at Large
Regulatory Affairs Director, Dohmen Life Science Services, LLC
Mary Armstrong has been in the medical device arena for over 40 years. She got her start working in the Biomedical Electronics Department at Ohio State University Hospital. After receiving a Master’s degree in Biomedical Engineering from Case Western Reserve University, she worked for the FDA Denver District Office as a Field Biomedical Engineer. She then moved to industry, working in Quality and Regulatory Affairs for a small, dental implant manufacturer and a large, life-sustaining device manufacturer. She has been consulting since 2001 in the medical device and tissue areas
Nan Matthews - Association Manager
President, The Matthews Group (TMG)
The Matthews Group has worked with RMRAS for over 15 years responsible for maintaining the membership database, sending out email announcements, acting a contact point for questions, as well as planning and executing their monthly meetings and annual seminars. Since 1998, TMG has specialized in technical meeting and conference planning for the medical device, biotechnology, dietary supplement and scientific research industries. Whether a local event with 50 in attendance or an international symposium hosting 200, Nan Matthews handles all meeting requirements from establishing the budget to site selection to website registration and credit card processing to day-of facilitation. Clients have included AdvaMed, AAMI, University of Colorado, Rocky Mountain Poison and Drug Center, ASME Colorado Section, and the Rocky Mountain Dietary Supplement Forum.
RMRAS is a nonprofit corporation classified by the IRS as a public charity under section 501(c)(3) of the Internal Revenue Code.