CQE with twenty seven years of experience in the Medical Device and Biomedical industries. In- depth knowledge of Regulations and Standards: QSR, ISO 13485, Canadian Medial Devices Conformity Assessment System (CMDCAS), ISO 14971, 21 CFR 1270 & 1271 (Human Tissue).
Titles Held: Vice-President, Quality Assurance; Director of Quality Assurance; Divisional Quality Assurance Engineering Manager; Quality Assurance Supervisor; Production Supervisor
- Substantive experience in Design Controls, Product Development, developing Quality System documentation such as Quality Manuals, Policies, SOP’s, Risk Management, CAPA, Supplier Audits
- Exceptional understanding of failure investigations, gap analysis, auditing, FDA & ISO inspections, remediation, company acquisitions, and Due Diligence experience
- Experience in responding to the FDA on 483’s and Warning Letters
- Successfully developed several quality systems for QSR and ISO 13485 compliance
- Extensive International QA and auditing experience in Mexico, France, England, Sweden and Japan
Thirty-three years of experience in the medical device and combination drug/device regulation, manufacturing, quality assurance and R & D arenas. Specialty is working on the pre-meetings and briefings with the FDA.
Titles Held: Corporate Senior Director of RA; Global Director of RA; Director of RA North America; Quality Assurance Manager; Senior Microbiologist
- Has extensive experience in interfacing with the FDA, at the district and headquarters levels, as well as with international regulatory authorities
- Strong international experience including international product registrations, CE mark approvals and import/export activities
- Extensive experience with compliance issues, Warning Letters, product recalls, facility inspections and resulting 483 responses and consent decrees
- Has obtained both PMA’s and 510(k)’s, In-Vitro diagnostics, IND, IDE, PLA and NDA approvals.
- RAC certified with extensive knowledge with combination drugs devices
Seasoned professional with thirteen of years experience in both Domestic and International Regulatory Affairs and Quality Systems. Strong 510(K) submission work and extensive knowledge of implementation of total quality system certifications for the Medical Device industry.
Titles Held: Manager of Quality Assurance and Regulatory Affairs; Senior Quality Engineer; RA Specialist
- Expert in Process and Software Validation; Knowledgable QSR Trainer
- Extensive experience with FDA Inspections and Quality system Audits
- Experience with Class II Intravascular Devices; clinical trials
- Experience working RA and QA systems in the US, EU, Asia Pacific and Latin America; CE Marking experience
- Certifications: RAC, ASQ, CQA, RAB-Certified Lead Quality Auditor