VP, Quality Management & Regulatory Affairs
Lori has 26 years of experience in the medical device field including Regulatory Compliance, Quality Assurance, Regulatory Affairs, Quality Systems, and Quality System Remediation. Lori is responsible to ensure full compliance of HDL Therapeutics’ manufacturing and established Quality Systems with Federal Regulations.
Lori began her FDA career in 1994 as an FDA Medical Device Registration Monitor and was a member of the FDA Foreign Inspection Cadre for Medical Devices. She conducted domestic and foreign Good Manufacturing Practice (GMP) and Quality System Regulation (QSR) inspections for premarket (including 510(k) and PMAs) and post-market inspections. Lori was an FDA Level II Certified Medical Device Investigator, which is an honor that is bestowed on FDA Investigators that have demonstrated special competence in conducting inspections. Lori has provided training at the FDA National Basic Medical Device School, which trains FDA Medical Device Investigators and industry groups on FDA inspection readiness.
Lori’s Professional Certifications include the Regulatory Affairs Certification (RAC/US) through the Regulatory Affairs Professionals Society (RAPS); Certified Quality Auditor (CQA) through American Society for Quality (ASQ); and RABQSA Principal Auditor (ISO 13485:2003) through Exemplar Global. Lori holds a BS degree in Chemistry from Xavier University in Cincinnati, Ohio.