Regulatory Affairs Executive

1 week ago


Haryana, India Geo Informatics Consultants Pvt. Ltd. Full time

We are hiring Regulatory Affairs Executive for a Medical Device Equipment company.

Key skills: Thorough Knowledge of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017
- 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 analyzing and interpreting test data

Regards

Pay: ₹10,572.25 - ₹25,000.00 per month

Schedule:

- Day shift

**Experience**:

- total work: 1 year (preferred)

Work Location: In person



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