Mike Byrom

Regulatory Affairs Manager @OrthoPediatrics

Warsaw, IN, US

Regulatory Affairs Manager | OrthoPediatricsOrthoPediatrics is the leading orthopediatric medical device company specializing in implants designed specifically for children, with a portfolio of 35 surgical systems spanning trauma & deformity, scoliosis, and sports medicine.In my role as Regulatory Affairs Manager, I drive global market access for both new and existing products. I partner with regulatory authorities in the U.S. and international markets to ensure compliance, quality, and safety, enabling successful product launches and sustained market presence worldwide.Key Contributions:Manage international regulatory approvals, renewals, and certifications across multiple regions, enabling continued global distribution and market expansion.Support U.S. regulatory submissions for new pediatric orthopedic implants, ensuring timely FDA clearance and market introduction.Collaborate with cross-functional teams (R&D, Quality, Clinical, and Commercial) to align regulatory strategies with business objectives.Ensure adherence to local and international health authority requirements, safeguarding patient safety and product performance.Core Expertise: Regulatory strategy • FDA submissions • International market access • CE marking/MDR compliance • Quality & safety assurance • Cross-functional collaboration

Oklahoma State University

Bachelor's degree, Biochemistry

Northeastern Oklahoma A&M College

Associate of Science - AS, Zoology/Animal Biology