Regulatory Affairs Executive

**Experience**: Minimum 02 Years
- **Salary**: 25K to 30k
- **Functional Area**:Legal, Regulatory
- **Industry**: Medical Devices/ Equipment
- **Medical Devices/ Equipment**: Permanent Job, Full Time
- **Job Location**: Plot No. 1792, HSIIDC, Industrial Estate, Rai, District - Sonipat, Haryana.
- **Education**:UG: B Tech in Mechanical, Bio Medical, B. Pharma, B. Tech Medical Science or a Science Discipline

**Key skills**:

- Through Knowledge of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017
- 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.
- 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

**Company Profile**:
One of the leading manufacturers and suppliers of Orthopedic Implants and instruments, founded in 1987 and has a manufacturing unit at Rai Industrial Area, District Sonipat, Haryana, and Corporate Office in Phool Bagh, Rampura, New Delhi Near Ashok Park Main Metro Station.