Brent Lewis Email & Phone Number

- Lead worldwide product registrations, regulatory compliance, and quality assurance for Advanced Sterilization Products (ASP) - Establish best-in-class quality goals and quality metrics trending. Apply problem-solving and system improvements - Ensure compliance with ISO 13485, US FDA, EU MDR, and other international health authority regulations - Develop and direct global programs and regulatory strategies to expedite global regulatory filings of products

Everett, Washington, United States

Accountable for the suitability and effectiveness of the ASP Quality Management System, driving continuous improvement activities for process accessibility, relevance, and efficiency for the workforce. Direct management of Document Control, Training, CAPA/NC, Supplier Quality, Complaint Handling, Postmarket Surveillance, Field Action, and IT application teams. The Quality and IT application teams have been brought together under my leadership to establish a QMS that enables empoyees to maintain compliance to our international medical device regulations and standards while empowering simplicity and data driven decision making in getting the work done.

Everett, Wa

Led the selection and implementation of enterprise IT systems. Continuing to drive simplification and efficiency through intelligent technology adoption and process improvement.

Seattle, Washington, United States

I teach the PHRMRA 536: Skills for the Regulatory Affairs Professional course in the Master of Science in Biomedical Regulatory Affairs program.

Bothell, Wa

Oversaw the quality and regulatory strategies for Oral Healthcare business, including broad portfolio of medical devices, OTC drugs, cosmetics, natural health products, and consumer products in numerous global markets (including US, Canada, EU, China, Japan, Korea, Russia, Australia, Mexico, and Brazil). Drove an aggressive QMS strategy to rebuild and bring into alignment with new business organization and structure. Strategically addressed critical gaps including risk management, clinical studies, verification & validation, supplier selection, supplier qualification, APQP, SCAR, postmarket surveillance, regulatory reporting, and CAPA. These efforts led to successful outcome in Medical Device Single Audit Program (MDSAP) audit of QMS.

Waukesha, Wi

Responsible for QMS strategy and effectiveness for 7 businesses in Global Services. Spearheaded development of a new QMS for non-regulated solutions in service to align QMS requirements with business needs.Business Development representative for QA/RA org. Leading standardization and best practice sharing for BD due diligence and QMS integration activities. Developed QMS training for BD Council.

Waukesha, Wi

* FDA Inspection support. * Led global investigation of catastrophic incident, reaching root cause and helping drive recall strategy.* Coordinated with global personnel and a consulting agency to plan, organize, and execute on-site audits of production and process controls across 11 global facilities. Analyzed observations to assess and establish remediation plans. * Performed deep dive analysis of part classification and incoming acceptance data. Presented results, observations, gaps, and suggestions for resolution and improvement to the executive team.

Developed and validated an electronic system for management of all of Merge's QMS (documents, training, CAPA, NCMR, audits, supplier management, etc). Spearheaded and directed consolidation of all of Merge’s quality management systems into a single system, re-written from the ground up to facilitate business effectiveness as well as regulatory compliance.Led multi-disciplinary team in authoring a new product development process for Merge Healthcare based on the IEC 62304 standard. Developed methodology for tailoring process deliverables based on product safety classification (for products ranging from non-medical devices to class II medical devices) and type of release (ranging from defect corrections to new product introductions). Process was used to bring over 300 product releases from concept to the market in 2 years.

Bellevue, Wa

Directed activities to address FDA opposition to premarket notification for new product indication. Appealed FDA's NSE decision, led meetings with FDA (including meetings with the Director of ODE), obtained clearance, and developed regulatory strategy allowing distribution of product with new indication as well as facilitating additional indications.

Bellevue, Wa

Spearheaded and completed quality system initiatives to resolve all outstanding FDA 483s and ISOnonconformities. Completed additional projects to improve multiple quality system processes including complaint handling, CAPA, and internal and supplier audits.

Audited clinical trials for GCP compliance, developed regulatory strategy for electronic data monitoring, and completed 21CFR Part 11 gap analysis.

Managed 2 clinical labs. Successfully led project to consolidate reference labs.

Developed and led product release and stability programs as well as those for facility environmental monitoring and water testing.

Raw materials analysis. Developed electronic logbook and lab metrics program to track real time FTE efficiency.

Set up new QC lab, including lab design and qualification of equipment.