Talented new executive brings 20 years of regulatory experience to the leading global provider of easy-to-use diagnostic solutions
SOUTH RIDING, VA. – January 19, 2023 – Slone Partners, a nationwide executive search firm for life sciences, biotechnology, and healthcare companies, has announced the placement of Amy Levin as Vice President of Regulatory Affairs at Mainz Biomed, a biomedical company that develops market-ready molecular genetic diagnostic solutions for life-threatening conditions.
In her new role, Levin will be charged with guiding the implementation and regulatory, clinical trial, and quality initiatives that are related to in vitro diagnostics. She will also contribute to key milestones for the FDA submission process for ColoAlert, the company’s highly efficacious and easy-to-use DNA-based detection test for colorectal cancer (CRC).
Levin has a successful track record of leading and collaborating with cross-functional teams and regulatory authorities to author, manage, and review required reports of the U.S. Food and Drug Administration (FDA) and international regulatory submissions. Previously, she served as Director of International Regulatory Affairs at Roche Molecular Systems after serving in several other roles with increasing leadership responsibilities within the company. She has also held other regulatory positions at various biotechnology companies in the San Francisco Bay area.
“Ms. Levin is an outstanding addition to our executive team and is well known as a strategic thinker, methodical problem solver, and inclusive people manager who is results-oriented,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “With these strong attributes and extensive professional experience, she will help drive our internal processes to support operational excellence as we execute our clinical trials and work toward FDA submission and approvals in the U.S.”
“I have spent a majority of my career in regulatory affairs and am excited to use my expertise and in-depth knowledge of the regulatory guidelines, landscape and processes to further advance ColoAlert with a focus on the U.S. as its key market as well as the company’s portfolio of cancer detection products,” said Levin.
ABOUT SLONE PARTNERS
Slone Partners delivers the leaders who build amazing and diverse life sciences and healthcare organizations – People Are Our Science®. Founded in 2000, Slone Partners specializes in delivering world-class C-suite leadership, executive, and upper management talent to the most promising and established biotech, diagnostics, research tools, healthcare, precision medicine, medical device, and laboratory services companies. With national and global clients, Slone Partners uniquely and precisely provides an array of executive search and advisory services, including diversity, equity, and inclusion strategy, to innovative life sciences and healthcare companies. To learn more about Slone Partners’ value proposition and processes, visit www.slonepartners.com or call 888.784.3422.
ABOUT MAINZ BIOMED NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert is marketed across Europe and the United Arab Emirates. The Company is currently running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.
Press release edited on 6/27/2023