Auditor, a Regulatory Affairs Consultant based in Luton, UK, boasts 15 years of expertise in Medical Device Regulatory affairs. Proficient in technical file construction, CE marking, global registration, and ISO standards compliance. Skilled in conducting USFDA audits, implementing UDI, and managing MDR/IVDR transitions. Holds certifications in ISO 9001 Lead Auditing and ISO 13485 Internal Auditing. Experienced in regulatory inspections for MHRA, USFDA, and MDSAP. Currently serving as an RA Consultant at Mirada Medical, driving regulatory strategies for market expansion. Past roles include Principal Consultant at Sushvin Consultancy Services and Regulatory Associate at Richardson Healthcare. Holds a Master's in Formulation Science and a Bachelor's in Pharmacy.