Brice Williams

Directed enterprise-level remediation and audit readiness for global medtech clients, leading a RA/QA team through DHF remediation and ISO 13485 alignment. Developed and implemented SOP harmonization frameworks and QMS realignment plans post-acquisition, building KPI dashboards to monitor performance.

Contributed to global QMS integration across multiple sites during product transfers and post-acquisition realignment. Led labeling harmonization across EMEA and APAC, ensuring compliance with FDA, EU MDR, and global standards. Supported regulatory change management for Class III surgical devices and delivered regulatory training workshops.

Led DHF and technical documentation remediation projects for FDA and MDSAP compliance, conducting internal audits and creating standardized protocols. Trained RA/QA and operations staff on ISO 13485, supplier qualification, and risk management best practices. Supported IVDR transition initiatives for diagnostic products.

Led cross-functional quality and regulatory documentation projects for MDR transitions. Oversaw STED formatting and document submission tracking across multiple business units.

Led a multi-year diabetes management study analyzing 2,500 EMR records, designing protocols in alignment with HIPAA and IRB standards. Conducted risk assessments, authored IRB submissions, and delivered SPSS-based data analysis. Taught human anatomy and assisted in surgical instruction.

Studied communications with a specialization, gaining foundational knowledge applicable to various professional fields. Developed strong analytical and interpersonal skills.