Quality Assurance and Compliance to International Regulatory Requirements- Medical Device Industry - Building up a system compliant to EN/ISO 13485 requirements- Identifying, defining, implementing and establishing processes for compliance- Performing Gap Analysis for existing systems required to achieve Regulatory Compliance- Risk Management for Medical Device in compliance to ISO 14971- Building of Technical Product File in compliance to the Medical Device directive for CE Marking - Internal Auditing for compliance to regulatory requirements, and follow-up on closure of non conformities- Identifying, defining, implementing and establishing processes for compliance to FDA’s 21 CFR Part 820, 21 CFR Part 11- Standards Worked with: ISO 13485, ISO 9001, ISO 14971, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304, EN ISO 10993 seriesKey Skills: Process Definition, documentation, implementation; Process Training; Vendor Management; Product Risk Management; Documentation of “Information for User” compliant to Regulatory Requirements; Internal Audit and NC Closure-CAPA; Product Verification and Validation