Job Description

Role and Responsibility -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.
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 BioMedical 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

Job Types: Full-time, Permanent

Pay: ?35,000.00 - ?45,000.00 per month

Schedule:

• Fixed shift

Experience:

• total work: 2 years (Preferred)

Work Location: In person