Molecular Testing Labs, a mission-driven, innovative health sciences company specializing in clinical diagnostics, has chosen Heinz Steneberg as its Vice President of Regulatory Affairs. Steneberg brings over 25 years of experience in regulatory, quality, and clinical roles in the medical device and diagnostic industry and has joined the company to support growing the business and their investment strategy to be a leader in diagnostic testing and home-based care.
“This is a fantastic opportunity to improve patient access to innovative diagnostic tests,” said Heinz Steneberg, new Vice President of Regulatory Affairs at Molecular Testing Labs. “It was apparent to me that Molecular Testing Labs has a strong culture of regulatory compliance and is dedicated to expanding access to diagnostics for all.”
Steneberg’s experience includes leadership of the quality management system for companion diagnostics (CDx) as well as clinical and regulatory strategies for CDx in the US and the EU as Executive Director of Regulatory Affairs at Quest Diagnostics. Additionally, he led regulatory organizations for blood screening and infectious disease product portfolios with a combined revenue of $1 billion as the Director of Regulatory Affairs at Roche Molecular Systems. Steneberg also served as Director of Regulatory Affairs at Abbott Diabetes Care, where he developed and executed regulatory strategies for submissions and post-approval supplements for blood glucose monitoring strips and glucose meters in Australia, Brazil, Canada, China, Japan, Singapore, and South Korea.
“Heinz’s extensive experience working with regulatory bodies around the world will amplify our ability to better serve all of our partners and patients,” said Eric Strafel, CEO of Molecular Testing Labs. “By further refining our products and services through innovation and compliance, we aim to reach more people and empower them in their own healthcare. We are grateful for Heinz sharing his knowledge and insights with us to ensure we provide the best diagnostics possible.”
About Molecular Testing Labs:
Molecular Testing Labs is headquartered in Vancouver, Washington. Molecular Testing Labs’ leaders are visionary in their approach to precision laboratory diagnostics and are committed to increasing accessibility and affordability of diagnostic testing via cutting-edge research and development, advanced logistics, and proprietary technology systems. They provide laboratory solutions through collaborative partnerships with payors, private healthcare institutions, universities, commercial partners, and public health organizations.
Molecular Testing Labs is a CLIA-certified and CAP-accredited, state-of-the-art reference laboratory that is passionate about bridging the gap and building bonds between the large communities that have access to diagnostics and the smaller underserved communities that deserve that same access. Molecular Testing Labs is pioneering distribution and specimen collection methods that open access to medical testing where geographic, financial, and stigma barriers create gaps in the delivery of healthcare.
About Heinz Steneberg:
Heinz Steneberg is a seasoned Regulatory Affairs leader with a comprehensive track record of successful regulatory submissions such as IDEs, INDs, BLAs, PMAs, 510(k)s, and EU IVDR Dossiers. He has worked in regulatory, quality, and clinical roles in the medical device and diagnostic industry for over 25 years. His previous leadership roles included Executive Director of Regulatory Affairs & Quality Assurance at Quest Diagnostics, Regulatory Affairs Director at Roche Molecular Diagnostics, Regulatory Affairs Director at Abbott, and Head of Regulatory & Clinical Affairs at Carl Zeiss Meditec.
Earlier in his career, Heinz was the Division Manager of TUV Rheinland of North America’s Medical Division, supporting CE Marking projects of his clients in the medical device industry. He is very passionate about bringing innovative solutions to patients to increase access to care.
In his management and leadership roles, Heinz focused on the professional development of his team members. He has helped to start the regulatory careers of people who entered the field without prior experience and supported the continual growth of his teams.
Heinz holds a BS degree in Precision Mechanics from the Polytechnic University Wilhelmshaven, Germany. He lives in the San Francisco Bay Area with his family and enjoys running, biking, and cooking.