San Jose, California, United States
Regulatory Affairs Professional with a proven ability to use and apply technical standards to support the development of comprehensive and highly effective regulatory strategies. Our team at Silk Road Medical thrives on ensuring the highest compliance standards for class III medical devices, with my role as a Regulatory Affairs Specialist II at the heart of these efforts. Holding a Master's degree in Medical Product Development Management from San Jose State University, I bring a comprehensive blend of academic knowledge and practical expertise to the table. In this role, I have authored and managed several PMA Supplements and Amendments for a Class III medical device with meticulous attention to detail and problem-solving skills. I have also authored a Pre-Submission and led interactions with the FDA. I am dedicated to lifelong learning and development within the regulatory sphere to facilitate the advancement of medical innovation with patient needs at the forefront of these efforts.
In this role I support and maintain regulatory processes and SOPs to ensure compliance with the latest applicable regulations. As well as supporting and authoring various PMA Supplements and Amendments to the FDA. My responsibilities also include reviewing and properly documenting proposed changes.