Regulatory Affairs Executive(Surgical Ind.)

3 months ago


Sonipat, India Jishu Enterprises Full time

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

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

Pay: ₹20,000.00 - ₹25,000.00 per month

Work Location: In person



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