Troy Quander

Background

About Troy Quander

Former FDA employee and accomplished Q&R Executive with proven industry experience with a focus on In-Vitro Diagnostics, Companion Diagnostics, Surgical Medical Devices, Digital Health (SaMD), and Biological Licensed Products. Over 25 years of combined experience in the fields of Regulatory Affairs, Quality, Regulatory Compliance, and Post Market Quality. In the field of Regulatory Affairs developed a successful track record of developing and implementing global regulatory strategies to ensure expedited market access for innovative products to meet unmet medical needs of patients. Expertise with development of INDs/BLAs; IDEs/PMAs; Pre-subs/510ks; Technical Document Files, & International Dossiers. Within the fields of Quality, Regulatory Compliance, and Post Market Quality developed successful track record of implementing state of the art Quality Systems and IT Tools, as well as leading successful US FDA & Global Health Authorities inspections. People are key. My objective is to build organzations that leverage their business acumen and knowledge of FDA/global regulatory and quality policies, regulations, standards, and directives in order to have the Regulatory Affairs, Quality, Regulatory Compliance, and Post Market Quality Departments to be recognized as key strategic business partners by fostering an innovative and agile culture to positively impact a business's growth and long term financial performance.