Job Description
Preparation of documentation for submission to FDA for medical device approval and/or response to FDA inquiries
Responsible for Compliance of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017.
Key skills:
Thorough Knowledge of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017
Desired Candidate Profile
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
Education-
UG: B Tech in Mechanical, Bio Medical, B. Pharma, B. Tech Medical Science or a Science
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