Neil Dow

Background

About Neil Dow

Career-long experience working in quality management systems functioning within an FDA regulated industry and in ISO environments. Experience includes management in manufacturing quality assurance, distribution and regulatory affairs. Currently am functioning in a small-company corporate environment. Strengths are in the area of establishment, implementation and maintenance of quality management systems compliant to US/FDA and international quality management system requirements, and regulatory affairs functions relative to FDA & CE marking. Also ensure all aspects of Regulatory Affairs for OTC Drug products, maintain WERCS registrations and perform research/evaluation of support data (clinical trials, etc.) for potential new products. Recent experience has been with hemp-derived CBD - gaining knowledge of growth, extraction, manufacture and labeling of various forms of CBD (tinctures, capsules, gummies & gelcaps.Key Competencies- Quality Systems Management to US and international standards- Regulatory Compliance (device & pharma)- ISO Compliance (13485/9001)- Canadian Medical Device Regulations (CMDR)- Functional knowledge of Australian Therapeutic Goods Regulations for Medical Devices- Management Representative- CE Marking: Medical Device Directive (MDD) & Personal Protective Equipment Directive (PPE)- IQ/OQ/PQ- Risk management- Design team member with R&D and product managers on design elements of products related to FDA compliance and CE marking- Strategist with all functions in the organization on matters related to regulatory submissions, CAPA, complaint handling and investigations, and compliance issues- Leadership and employee development/mentoring