RegEx MVPs

RegEx MVPs are RAPS members who go above and beyond in Regulatory Exchange (RegEx) to make sure our community stays informed and educated by answering questions and leading discussions. They respectfully share their thoughts and experiences — for the good of our community and our profession.

MVPs are identified by this badge, which lets you know your question is being answered by one of our top contributors.

Want to become a RegEx MVP? Scroll down to the bottom of this page to learn more — but keep in mind that RegEx MVPs are longtime contributors. You can't become one overnight. But you can begin your journey today by starting a new discussion!

Armin Beck, MS, MBA

Chief Executive Officer, Suntrix Consulting

I’m an entrepreneurial medical device executive with a broad, multi-disciplinary background, I'm currently the CEO of Suntrix Consulting LLC, providing all aspects of regulatory/quality/clinical expertise. I started as an interim manager for R&D, Quality/Regulatory/Clinical Affairs & Operations organizations. READ MORE 

Ronald Boumans, MS

Founder, Boumans Regulatory Consulting B.V.

I have worked with medical devices in many roles since 1987: R&D, distribution, standardization, quality of life research, and market surveillance for a competent authority, high-end regulatory consulting, and worked as a PRRC. Now, I’m an independent consultant with a focus on ‘difficult’ issues. This motto refers to flying a plane: a good pilot can land his plane in a storm; an excellent pilot knows how to fly around bad weather. READ MORE 

Stephanie Grassman, MSc., P. Eng (APEGA)

Managing Director, Owner and Founder, MedTechXperts LLC

I have a BSc. Mechanical Eng., MSc. Biomedical Eng., and a P. Eng (APEGA). I’m the managing director, founder, and owner of MedTechXperts LLC, which is based in Switzerland. I have 30 years of professional experience in various technical fields and medical devices in the following roles: QMS/ RA/ clinical affairs manager, senior development engineer, NB auditor/ reviewer, coach, project leader, researcher and clinical expert. READ MORE 

Ames Gross, MBA

President, Pacific Bridge Medical

I founded Pacific Bridge Medical in 1988 and have guided hundreds of medical companies on regulatory and business development in Asia. I was named one of MD&DI’s top 100 medical executives in 2008, I’m a recognized expert, frequent author, and featured speaker at global industry conferences. I hold a BA, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University. READ MORE 

Christoph Kiesselbach

Partner, Schrack & Partner

I am a biologist by training with experience in preclinical research and development of drugs, including regulatory aspects of drug development and approval. Since 2013, I have consulted medical device manufacturers in quality management and regulatory affairs for medical devices and combination products, including the implementation and maintenance of quality management systems, device development, verification, validation, and certification/approval, with a main focus on Europe and additional international locations. READ MORE 

Vic Mencarelli

Director – Regulatory Affairs, Orveon Global US LLC

For the past three years, I have been Director – Global Regulatory Affairs for Orveon Global US LLC. I have been in regulatory affairs in some form for the past 20+ years with experience in cosmetics, OTC pharmaceuticals, natural and organic products, chemical compliance, mergers and acquisitions all in a global scope. Before starting in regulatory, I was a microbiologist in the industry for eight years. READ MORE 

Olga Peycheva

Regulatory and Study Start-Up Specialist, Solutions OP Ltd

I'm a Regulatory and Study Start-Up Specialist at Solutions OP Ltd. I have over 20 years of experience in clinical research. My special interest is in setting up clinical trials and supporting start-up pharma and biotech companies. I'm a member of the Research Ethics Committee in the UK, and I'm involved in focus groups. I enjoy working with healthcare professionals, the industry, and the regulators. READ MORE 

Grace F. Palma, MBA

Principal, China Med Device, LLC (part of Accel Groups)

I’m the Principal at China Med Device, founded in 2011, with offices in the US, China, and Japan. I’ve helped launch hundreds of medical devices across diverse indications. I’m a national speaker and trainer on US and China Medical device regulations for RAPS, AdvaMed, and NMPA. I’m bilingual and bicultural with 30 years of experience in US & China regulatory, clinical, commercial affairs, and strategic partnership. I have a BS from Beijing University and an MBA from Yale University. READ MORE 

Kevin Randall, RCC-MDR, RAC (U.S., CAN, EU), ASQ CQA 

Principal Consultant, ComplianceAcuity, Inc.

Since entering the profession in 1995, I have continuously contributed to the goals of global medical product companies from start-ups to large enterprises. I’ve logged 30+ years achieving premarket authorizations, sustainable QMS and regulatory compliance. Clients always enjoy my QMS trainings. I have a proven aptitude and track record of reforming ailing regulatory affairs and setting up systems from baseline. READ MORE

Arvilla Trag

Principal Consultant, CMC Compliance Services LLC

I have over 33 years of experience in biotechnology CMC regulatory strategy and GxP compliance, including preparation of Module 3 for 8 BLAs and dozens of INDs, plus comparability strategies and reports, FDA meetings, pre-meeting packages, and meeting strategies; CMC amendments, positioning of product for expedited review requests, development of submission strategies to meet changing deadlines and responding to FDA questions/observations. READ MORE 

Richard Vincins

Director of Regulatory & Quality, MD Compliance

I work for MD Compliance as Director of Regulatory & Quality, responsible for QA/RA activities. In this role I’m responsible for the regulatory submissions, quality systems, audits, and providing regulatory expertise in national and international regulations. I hold ASQ CMDA and CQA certifications and a RAC- Medical Devices through RAPS. I graduated from Bridgewater State College, MA, with a bachelor’s degree in biomedical biology. READ MORE 

How to become a RegEx MVP

  • Must be a RAPS member in good standing

  • Be active on RegEx for at least one year

  • Post four times a month on RegEx

  • Pass a quality check to ensure your messages are providing value to our community

Questions? Reach out to RAPS Community Manager Brooke Keith at bkeith@raps.org.