Regulatory Affairs Specialist

DHR Holding India; Bengaluru; Remote; INR 900,000 - 1,300,000; Full time

Job summary

Masimo is seeking a Regulatory Affairs Specialist to obtain and document Indian regulatory clearances for its medical device products. You will be the sole RA representative on project teams for new products or changes.

Role includes supporting APAC filings, coordinating with global teams on local regulation changes, and maintaining product listings with Indian authorities. Remote work is eligible, with travel as needed.

Qualifications

• Minimum 2 years of work experience in a medical device Class II/III environment.
• Local Indian regulatory experience in the medical device industry is required.
• Working knowledge of IT equipment import/export rules and BIS certs application process.

Responsibilities

• Support the APAC regulatory team managing international and domestic filings/registrations, including drafting and compiling of technical files, tender request submission and any audit finding responses.
• Communicate with headquarter regulatory team on local regulation changes with impact assessment.
• Assist in communications with global regulatory representatives to assist in filings and responses to inquiries from health authorities.
• Assist in maintaining product listings and establishment registrations with India regulatory authorities.

Skills

Regulatory affairs

Medical devices

India regulatory experience

Import/Export rules

Tools

BIS certification process

Job description

Job Summary

The Regulatory Affairs Specialist is responsible for obtaining and documenting our mission-critical, Indian regulatory clearances for Masimo's amazing innovative medical device products. The individual will be the sole RA representative on various project teams for new products or product changes.

Responsibilities

• Support the APAC regulatory team managing international and domestic filings/registrations, including drafting and compiling of technical files, tender request submission and any audit finding responses.
• Communicate with headquarter regulatory team on local regulation changes with impact assessment.
• Assist in communications with global regulatory representatives to assist in filings and responses to inquiries from health authorities.
• Assist in maintaining product listings and establishment registrations with India regulatory authorities.

Requirements

• A minimum of 2 years of work experience in a medical device Class II/III environment.
• Local Indian regulatory experience in the medical device industry is required.
• Working knowledge of IT equipment import/export rules and BIS certs application process.

Travel and environment

• Ability to travel as needed.

Preferred qualifications

• Experience in patient monitor systems, hospital-based products, software or electronic device products.
• Knowledge of regulatory submission requirements for India Class II medical devices.
• Experience in Quality Systems per ISO 13485.

This position is eligible for a remote work arrangement.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.