Minnesota, USA
Quality and Regulatory Advisor
MedTech, BioTech, Pharmaceuticals, Medical Devices
Worldwide
Quality and regulatory expert partners
Areas of Expertise
Based in Minneapolis, MN, and the heart of MedTech and BioTech innovation, Quality & Regulatory Expert (QRx) Partners strives to be the partner of choice for companies that want to realise clear business benefit from their regulatory and quality management system investment in terms of effectiveness, efficiency, risk management, compliance, and operational excellence. They can help you avoid adverse regulatory actions, ensure timely market access, and effective post-market follow-up. With over 85 years of combined experience among their expert Partners: Jackie Torfin, Mark Swanson & Steve Gompertz, QRx strives to support its customers to ensure that their investment in consulting services provides sustainable business value beyond compliance and produces results favorable to the business.
Working with GTM Global
GTM is delighted to partner with QRx, who provide effective and added value quality management systems to ensure critical compliance for ambitious high-growth MedTech devices, Pharma, BioPharma, CRO and Academia companies looking to expand into North America and globally.
Principal Services
Key Advisors
Steve Gompertz
Chief Operating Officer & PartnerSteve has been a leader in Quality Systems management for 30 years. His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican Biothermal, St. Jude Medical and Boston Scientific.
Mark Swanson
Healthcare Regulatory AdvisorMark has been a leader in Quality and Regulatory for over 25 years. His career includes roles in quality engineering, design assurance, audit, and quality management for companies, including St. Jude Medical and Medtronic, and has provided guidance to numerous medical device and pharmaceutical manufacturers of all sizes.
Jackie Torfin
Partner / Client Relations and MarketingJackie has over 30 years experience and deep expertise in quality, regulatory, pre-clinical and clinical compliance. She has served in Senior Global roles for companies including Beckman Coulter, NAMSA, CIMA Labs, PDL BioPharma, Arizant/3M, and Heraeus.
Christina Pecoraro
Account ManagerBringing over a decade of experience, Christina has been employed in quality assurance, medical device regulatory affairs, and business development. She gets involved in supporting all sizes of medical device companies such as Boston Scientific and Medtronic, to small startups.