Rocky Mountain Regulatory Affairs Society
Rocky Mountain Regulatory Affairs Society

About RMRAS

Our Mission

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

  • 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.
  • Provide professional interaction opportunities for members.
  • Disseminate job opportunities in companies regulated by FDA and FDA-like entities to the members.

Steering Committee

Darren Doherty - President

Senior Director of Operations,  Flagship Biosciences 

Darren Doherty has B.S. in Chemical and Biochemical Engineering from the Colorado School of Mines and an MBA from the University of Colorado Denver.  Darren has 15 years of quality, regulatory, and operations experience across the medical device, pharmaceutical, and biotech industries. He is currently the Senior Director of Operations at Flagship Biosciences. Flagship Biosciences is CAP/CLIA laboratory located in Broomfield Colorado and offers histology, pathology, and image analysis services to deliver the most accurate and informative tissue data available to clients. As head of the Colorado Operations Darren leads the team that is responsible for the operational and delivery aspects of Flagship’s Colorado location. Darren currently is President of the Rocky Mountain Regulatory Affairs (RMRAS) association

Ann Niedzinski, MT(ASCP), CHS(ABHI) - Secretary

VRL Eurofins 

Carolyn Braithwaite-Nelson - Treasurer

Principal Biocompatibility SME, Abbott Labs

Carolyn Braithwaite-Nelson is the Principal Biocompatibility SME for Abbott Labs. Carolyn has over twenty years of experience working for global medical device manufacturer’s, providing technical, regulatory, and quality support for microbiology and toxicological issues. Her current responsibility include ongoing strategic and technical support for biological evaluation and technical support as needed for sterilization, manufacturing cleanrooms/controlled environments, particulate, bioburden and bacterial endotoxin testing programs.  Carolyn is currently a member of ISO TC 198 WG08 and several ISO TC 194 Working Groups.  She is also an active member of several AAMI ST sterilization and BE biocompatibility working committees.

Malissa Sailakham - Social Media Director

Quality Management System professional with 20 solid years of experience in Medical Device and IVD.  Specializes in QMS compliance, development, implementation, and evaluation of systems to ensure products and operations meet corporate objectives, integrity, and efficiency standards established by the organization and regulatory requirements.  Institutes continuous process improvement focused not only on product and service quality, but also on the means to achieve it.

Daniel Simpson, Director at Large

Director of Regulatory Affairs, DCN Diagnostics

Dan has spent most of his 30 plus years of his professional career in the In vitro Diagnostic (IVD) industry.  Originally a microbiologist by training, Dan developed IVDs for human and veterinary use for the early part of his career.  In 2008 he made the switch to Regulatory Affairs, Quality and Clinical Affairs and became the Director of Regulatory, Quality, and Clinical Affairs at Corgenix Inc in Broomfield Colorado.  Dan served in this position for 14 years and grew the company’s product portfolio, regulatory compliance systems, and strategic partnerships.    In 2022, Dan became the Director of Regulatory Affairs at ERI group, a full-service medical device consulting firm, and led the regulatory affairs consulting group.  During this time Dan worked with both IVD and medical devices companies to make their product ideas into reality and navigate the complex worldwide regulatory framework.  In 2024 Dan opened his own independent regulatory consulting firm and as of 2025 he became the Director of Regulatory Affairs at DCN Diagnostics leading up the regulatory consulting services in the Clinical Research Organization within the company.  Dan’s passion continues to be getting novel medical devices and IVDs out to the patients that need them.

Emily Becker - Director at Large

Chief Regulatory Officer, OnemataDC

Emily is responsible for implementing and maintaining OnemataDC’s global Regulatory Affairs program and is also responsible for OnemataDC’s Government Affairs, liaising with state and federal legislative bodies and government agencies to represent the company’s viewpoints and actively participate as a stakeholder. Emily has a passion for living in the grey of regulations to creatively and innovatively achieve compliance with unwavering integrity in support of OnemataDC and its clients' efforts.

Brandyn Abbott - Director at Large

Chief Quality Officer, OnemataDC

Brandyn Abbott, Chief Quality Officer, OnemataDC  Brandyn Abbott’s experience in the Life Science industry has focused on all aspects of Quality and Operational excellence for the past fifteen years. Currently, Brandyn is the Chief Quality Officer at OnemataDC.  OnemataDC is a Quality and Regulatory consulting organization supporting pre and post market efforts for Medical Devices, Tissue, HCT/Ps, and Combination Product companies globally. As head of Quality Brandyn develops, drives and delivers strategies to support quality and operational efficiency for both OnemataDC and their clients.

Mary Armstrong - Director at Large

Regulatory Professional -  Retired

Mary Armstrong was 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 consulted in the medical device and tissue areas from 2001 to 2018.

Nan Matthews - Association Manager

President, The Matthews Group (TMG)

The Matthews Group has worked with RMRAS for over 20 years 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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