Rocky Mountain Regulatory Affairs Society
Rocky Mountain Regulatory Affairs Society

About RMRAS

Our Vision

Advance the understanding and practice of worldwide medical Regualtory Affairs for members in the Rocky Mountain region. 

Our Mission

  • Provide for the professional development of members.
  • Provide high quality affordable educational programs.
  • Provide an environment for "members to teach members" best practices and relevant theory.
  • Disseminate job opportunities in local companies to members. 

Steering Committee

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

 

Evelyn Cadman is the Principal Consultant for FDA Compliance Simplified, offering technology evaluation, product development and regulatory affairs services to the food, cosmetic, nutritional supplement and biotech industries. She has worked in regulatory affairs and product development for FDA-regulated products since 1997 and was previously a Pharmacologist at Abbott Laboratories. Evelyn recently authored and edited chapters on dietary supplement, cosmetic and food regulations in Fundamentals of US Regulatory Affairs, 8th Edition, and a chapter on food labeling in Nutritional Genomics: The Impact of Dietary Regulation of Gene Function on Human Disease.

Georganne Brown, RAC US, EU, Can, - Secretary

Principal Consultant, Regulatory Relief Resources, LLC.

 

Georganne has been involved in regulatory affairs activities since 1976. She gained extensive experience supporting the development and marketing of medical products through clinical, registration and compliance activities, as both an industry employee and independently on a contract basis. Previously, Georganne was employed by Gambro BCT for 10 years. She has been a member in good standing of RAPS since 1977.

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. - Program Chair

Senior Director 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.   

 

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. 

Contact Us

Rocky Mountain Regulatory Affairs Society

 

Phone: +1 (303) .843-6414

E-mail: info@rmras.org

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