Mike Billig
About Mike Billig
Mike Billig's Role as Vice President, Regulatory Affairs
Mike Billig serves as the Vice President of Regulatory Affairs, leveraging over three decades of experience in the medical device industry. His extensive career encompasses regulatory affairs, quality systems, clinical research, and general management. Throughout his tenure, he has been instrumental in helping numerous medical device companies navigate the complex regulatory landscape. His role focuses on ensuring compliance with industry standards and securing approvals from various regulatory bodies worldwide.
CEO of Experien Group
Since co-founding Experien Group in 2003, Mike Billig has served as its CEO. This clinical and regulatory consulting firm specializes in offering expert guidance to medical device companies. Under his leadership, the firm has effectively steered clients through the intricate regulatory processes. Experien Group has established a reputation for its deep expertise and successful track record in obtaining regulatory approvals, ensuring that medical device companies meet the necessary standards for market entry.
Mike Billig's Experience in Medical Device Regulatory Affairs
Mike Billig boasts over 35 years of experience within the medical device sector, focusing primarily on regulatory affairs and quality systems. He has been pivotal in navigating the regulatory approval processes across multiple regions, including the U.S., Europe, Canada, Central and South America, and Asia. His comprehensive understanding of the global regulatory environment has enabled him to secure approvals for hundreds of medical device products, showcasing his proficiency and dedication to advancing medical technology.
Educational Background of Mike Billig
Mike Billig holds a Bachelor of Science (BS) degree in Microbiology from the University of Minnesota. This solid educational foundation in microbiology has been essential in his extensive career in the medical device industry. His scientific knowledge coupled with his experience in regulatory affairs has equipped him with the expertise needed to oversee and implement robust quality systems and navigate regulatory challenges effectively.