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Melinda Swanson

Regulatory

Ms. Swanson entered the Cardiovascular Device space in 1995 and is a career regulatory and clinical professional who provides global, strategic regulatory solutions for medical devices at all stages of development in the product life cycle.  With more than 22 years of experience in the health products industry designing strategies, which expedite progress to market and extend market life, Ms. Swanson brings her broad knowledge and clinical insights to Radux Devices. Ms. Swanson was most recently Senior Director, Regulatory Affairs and Clinical Research at Vascular Solutions where she was responsible for building and maintaining the regulatory infrastructure to support multiple product lines for interventional cardiology/radiology, vein ablation, and hemostatic products. Her key leadership role included developing, implementing and directing regulatory strategies for securing worldwide market authorization for Class II products.  Ms. Swanson has also served as an interface with the FDA and international regulatory agencies and has developed quality systems and participated in bioresearch monitoring audits to ensure regulatory approval for numerous submissions.

Ms. Swanson received her undergraduate degree in biotechnology from Minnesota State University-Mankato.