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Regulatory Affairs Executive

Regulatory Affairs Executive

MACOM

1 - 5 years

2 - 3 Lacs

Sonipat Rai

Posted:2 months ago| Platform:

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Skills Required

Regulatory Affairs Regulatory Regulatory Affairs management Quality System Standards Medical Devices Good Manufacturing Practices Risk Management

Work Mode

Work from Office

Job Type

Full Time

Job Description

1. Preparation of documentation for submission to FDA for medical device approval and/or response to FDA inquiries 2. Responsible for Compliance of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO14971:2012 & Medical device Rules 2017. 3. Demonstrated success in a start-up, entrepreneurial work environment 4. 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

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Regulatory Affairs Executive