Regulatory and Sustain Engineer with over 7.2 years of experience in medical device documentation, remediation, and design control. Proven expertise in MDR gap assessments, technical file remediation, and product development across urological devices. Proficient in managing complete DHF documentation and STED files for Notified Body (NB) submissions. Strong background in cross-functional collaboration, quality assurance, and compliance with EU MDR and ISO standards.