Senior Consultant, Quality and Regulatory Affairs

Rachel Paul has over 13 years of experience in the medical device industry as well as international experience in high-risk device regulatory submissions and quality assurance requirements. Rachel’s accomplishments include: 9 FDA 510(k) clearances; 10+ EU Technical Files/Design Dossiers; writing more than 25 Clinical Evaluation Reports; implementation of 5 quality systems to ISO 13485/CE Marking/FDA QSRs/CMDCAS; quality system gap assessment and improvements; auditing for compliance to multiple standards; conducting training to various international regulations; more than 30 global regulatory strategy analyses; and compilation and submission of numerous registration dossiers for international marketing authorization.