Regulatory Affairs Executive

MACOM; Rai; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

MACOM in Haryana, India seeks a Regulatory Affairs professional to manage documentation for FDA submissions for medical device approvals and respond to FDA inquiries.

The role ensures compliance with MDD 93/42/EEC, ISO 13485:2016, ISO 14971:2012, and Medical Device Rules 2017, and requires thorough knowledge of GMP and Quality System Standards, with startup/entrepreneurial experience preferred. Experience with risk management and regulatory audits is beneficial.

Responsibilities

• 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, ISO14971:2012 & Medical device Rules 2017.
• 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 description

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