NEW WORLD REGULATORY SOLUTIONS - Key Persons
Job Titles:
- Director of Scientific Affairs
Job Titles:
- Director, Quality Systems / Compliance
Katrina has over 20 years experience in the medical device in vitro diagnostic industry specializing in the areas of Quality Systems, Global Regulatory Compliance, Technical Support, Training, and International Registrations/Licensing/CE Marking. During that time, she has assumed increasingly responsible management positions in those areas.
Katrina's approach to compliance is practical, strategic, cost-effective and hands-on. She has expertise in designing customer-tailored quality systems/reworking failing ones, developing a world-class technical support team, post market surveillance, recalls, medical device/vigilance reporting, ISO certifications, CE marking, international medical device registrations/licensing, and auditing (internal and supplier).
Katrina holds a BS Natural Sciences/Mathematics from Thomas Edison State College. She is committed to quality and continued professional education. Katrina is Regulatory Affairs Professional Society (RAPS) RAC-US certified and is an American Society for Quality (ASQ) Certified Quality Auditor (CQA).
Maureen, Glenn and Katrina worked together for over 10 years at Carter-Wallace, a pharmaceutical, OTC, medical diagnostic products company, combining their regulatory, compliance and technical expertise, which is favorably received by regulatory bodies.
Glenn and Maureen's strategic skills have produced industry firsts in CLIA waiver status for rapid point-of-care tests for mononucleosis and Lyme disease.
Maureen was also instrumental in gaining the first sooner than missed period claim for a widely distributed OTC pregnancy test, which helped to double the brand sales in 2001 and moved the product to the #2 pregnancy test on the market with a 12.3% market share.
Job Titles:
- Manager, Regulatory / Clinical
- MT ( ASCP ), Manager, Regulatory / Clinical
Suzan has over 37 years of experience in the clinical laboratory and diagnostic industry. She began her career as a Medical Technologist working in reference and hospital laboratories, managing physician office laboratories and worked as a researcher at a major instrument manufacturer.
Suzan has assumed increasingly responsible management positions in Technical Services, Training, and Technical Support. Her expertise extends to product trend and customer complaint analyses, and Medical Device Reporting to the FDA, as well as to clinical trials management for Phase 1 drug studies including study planning and study conduct, and in the preparation of clinical trial study reports in support of 510(k) and NDA submissions.
Suzan holds a BS in Medical Technology from Fairleigh Dickinson University and has been a registered Medical Technologist for 37 years.