Leslie M.

I am an experienced project management professional with 15+ years of progressive experience and a diverse client portfolio. I have consulted for companies to help them achieve their quality, project management and compliance goals. My experience includes working in/with biotech, medical device, pharmaceutical, and oil& gas, regulatory compliance and quality management systems including: * ISO 9001:2015 (Quality Management) *ISO 13485:2016 (Medical Device Quality Management) * ISO 14001:2015 (Environmental Management)* ISO 31000:2018 (Risk Management) * 21 CFR 820, (Medical Device)* 21 CFR 211 (Pharmaceutical cGMP) * 21 CFR 111 (Dietary Supplements)*21 CFR 11 (Electronic Record/Electronic Signatures) * FDA responses/corrective actions for 483s/Warning Letters * Risk management*Supplier management * Complaint management *Regulatory agency reporting * 3rd party audit responses and CAPA development*Internal auditing * FDA Medical Device Establishment registration and Device Listings