Mainz Biomed appoints Amy Levin as VP of regulatory affairs

Mainz Biomed NV, a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the appointment of Amy Levin, RAC, as Vice President of Regulatory Affairs.

In this role, Levin will be in charge of guiding the implementation and regulatory, clinical trial and quality initiatives that are related to in vitro diagnostics. She will 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). She will also be responsible for bridging the gap between business development and regulatory, clinical trial and quality teams to ensure the implementation of programs adhere to all regulatory specifications and meet customer expectations and goals.

“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.”

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 worked as Director, Roche Molecular Diagnostics (RMD) International Regulatory Affairs at RMD after serving in many roles with increasing leadership responsibilities within the company. While there, Levin drove the development and implementation of regulatory strategies for introducing new products in the marketplace and negotiated with worldwide health authorities to enable expeditious approval and importation of products across more than 50 countries. She has also held other regulatory positions at multiple Biotechnology companies in the San Francisco Bay area.

“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.
MB Bureau