Regulatory Affairs Specialist

Job Summary

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