Organization / Workplace

Location

Occupation

Industry

Medical / Health Care / Pharmaceuticals

About

15 years of direct experience in successfully managing complex projects, LOBs and up to 50 employees. Proven skills and expertise in: Risk Management, System & Software-Validation, SDLC, Software-Testing, 21 CFR Part 11 compliance, GAMP compliance, Annex 11 compliance , HIPAA compliance and Quality standards & Regulatory implementation (9001, 90003, 13485, 27001, ISO 14971, TL9000, ISO/IEC 9126, IEC 62304). A senior lecturer in Quality, Compliance and Software Validation Experience in implementing the Risk based Validation & Compliance Approach in a variety of medical companies. High level of knowledge, experience and understanding of: cGMP, 510K & PMA Submission, HIPAA, General P...