Regulatory Affairs Specialist

Supporting global product registrations, the full-time Regulatory Affairs Specialist will develop regulatory strategies for product changes, prepare FDA 510(k) and international submissions, and collaborate with cross-functional teams to ensure compliance in a hybrid work environment. Key responsibilities Research and identify product classification and contents for global regulatory submissions Lead the preparation of documents for internal audits and inspections while assessing compliance of product design and labeling changes Develop and maintain product technical files, ensuring adherence to domestic and international regulations Required qualifications Bachelor's degree in physical/biological sciences or engineering preferred, or equivalent education and experience Two years of experience in Regulatory Affairs, Clinical Affairs, Product Development, or Quality Assurance preferred Knowledge of U.S. and/or international medical device regulations and standards Experience preparing regulatory documentation in compliance with regional requirements Quality Assurance or Regulatory Affairs Certification (RAC) desired