Job Description

Number of Openings : 02

Experience : Minimum 02 Years

Salary : 35K - 45K

Functional Area : Legal, Regulatory

Industry : Medical Devices/ Equipment

Employment Type : 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:

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

### 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.

### 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
### Company Profile:


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

Note: Kindly mail your resume at hr@siora.net . Our HR team will call you for the interview if your resume is shortlisted.