James (Rusty) Lusk has 40+ years of experience in FDA/ISO regulated industries from early-stage to Fortune 100 companies. He is currently with Quality Systems International, a consulting company serving FDA/ISO regulated industries.
He is the co-inventor of a non-invasive device intended to delay or reverse cardiovascular disease and improve quality of life. He co-founded LifePulse, LLC to develop and market the product.
He is an active member and past President of Orange County Regulatory Affairs (OCRA), a nonprofit organization educating the regulatory professional.
- MBA, Pepperdine University
- BS, Biological Sciences, The University of California, Irvine
- AA – Electronics, Orange Coast College
Domestic and international certifications:
- Regulatory Affairs Professional Society: RAC (US & EU)
- American Society for Quality: CMQ/OE, CQE, CQA, CQAHACCP
- Quality Management Systems Lead Auditor – Exemplar Global (Certification allowed to expire 2019)