Extended Team Profile

Liz Lison, BS Medical Science

Ms. Lison has more than 20 years experience in the diagnostics industry, having held various senior management positions in regulatory affairs, quality assurance, operations management, customer service and sales and marketing. She has experience working with companies governed by FDA, ISO, CLIA and HIPAA regulations

Most recently she has worked with a number of entrepreneurial diagnostic companies to define their regulatory strategy and implement operational infrastructure to bring cutting-edge products from concept to commercialization. This has included implementing design control systems and facilitating meetings with the FDA. Ms. Lison also has experience of the regulation of healthcare products in the EU and has worked with several companies to achieve compliance with the In Vitro Diagnostics Directive and ISO 13485 certification.

Ms. Lison has a BS in Medical Science from the University of Bradford (UK). She is a member of the Regulatory Affairs Professionals Society.

Specialties:

FDA regulatory affairs
Regulatory strategy
Quality assurance
ISO certification
Operations management
Customer service, sales and marketing

Work Experience:

Syva UK (Diagnostics divison of Syntex)
PharmChem Laboratories
Naxcor
XDx

Education:

University of Bradford (UK)
   BS, Medical Science