Detailed-oriented and result-driven Regulatory Affairs Specialist with over 5 years of experience in the medical device industry specializing in regulatory submissions and auditing quality management system(QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, EU Medical Device Regulation (MDR), and ISO 14971, ensuring organizations meet regulatory requirements and maintain high-quality standard An in depth knowledge in risk assessment, root cause analysis, and developing corrective and preventive actions (CAPA). Strong analytical skills, attention to detail, and a commitment to continuous improvement.
Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities.
Possesses versatile skills in project management, problem-solving, and collaboration. Brings fresh perspective and strong commitment to quality and success. Recognized for adaptability and proactive approach in delivering effective solutions.
