Regulatory Affairs Executive

Minimum B. Tech in Mechanical, Bio Medical, B. Pharma, B. Tech Bio Medical Science or a science discipline

• 2+ years of experience implementing test strategies, test plans and test cases for validation and verification in FDA-compliant medical device industry

• Demonstrated success in a start-up, entrepreneurial work environment

• Thorough knowledge of FDA Quality System requirements, ISO 13485:2012 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards

• 2+ years of experience in verification/validation of products incorporating scalable data acquisition, processing, management, and reporting functionalities.

• 2 or more years of experience with QMS implementation that complies with, MDD /93/42/EEC, ISO 13485 and ISO 14971 standards.

• Lead role (administrative or technical) in one or more FDA submissions for approval of a medical device

• Project management skills and proficiency and analysing and interpreting test data