Regulatory Affairs Executive @ MACOM

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Regulatory Affairs Executive

MACOM
1 - 5 years
Sonipat
2 months ago
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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

Job Classification

Industry: Medical Devices & Equipment
Functional Area / Department: Legal & Regulatory
Role Category: Corporate Affairs
Role: Regulatory Affairs Compliance
Employement Type: Full time

Contact Details:

Company: MACOM
Location(s): Sonipat

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

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MACOM

We are a manufacturing industry company based in Delhi NCR. With extensive experience in versatile manufacturing, we are committed to delivering high-quality products and solutions across multiple sectors. In addition to our manufacturing expertise, we strive to streamline the hiring process, ensur...

Regulatory Affairs Executive @ MACOM

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