Regulatory Affairs/Quality Assurance Executive

About the job

Key Responsibilities

1. Prepare and submit regulatory filings for medical device registrations and approvals

1. Maintain product licenses, registrations, and certifications

1. Ensure compliance with applicable regulations and standards, including CDSCO requirements in India and ISO 13485 standards

1. Prepare and maintain technical documentation, device master files, and regulatory dossiers

1. Review product labeling, instructions for use (IFU), and promotional materials for regulatory compliance

1. Monitor changes in global regulatory requirements and assess their impact on products

1. Coordinate with quality assurance, R&D, manufacturing, clinical, and marketing teams

1. Support regulatory inspections and audits

1. Assist in post-market surveillance and vigilance reporting activities

1. Communicate with regulatory agencies regarding submissions, approvals, and compliance matters

Skill(s) required

MS-Excel MS-Word

Who can apply

Only those candidates can apply who

1. have minimum 1 years of experience

1. are from Delhi only

Other requirements

1. Regulatory documentation and submission preparation