Industry: Medical Devices/ Equipment
Functional Area: Legal, Regulatory
Employment Type: Permanent Job, Full Time
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
Discipline
Job Types: Full-time, Permanent
Experience:
- total work: 3 years (Preferred)
Work Location: In person
