Regulatory Affairs/Quality Assurance Executive

About the job:Key Responsibilities:

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

2. Maintain product licenses, registrations, and certifications

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

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

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

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

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

8. Support regulatory inspections and audits

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

10. Communicate with regulatory agencies regarding submissions, approvals, and compliance mattersWho can apply:Only those candidates can apply who:have minimum 1 years of experienceare from Delhi onlyare Computer Science Engineering studentsSalary:₹ 3,60,000 - 6,00,000 /yearExperience:1 year(s)Deadline:[hidden]:59:59Skills required:MS-Word and MS-ExcelOther Requirements:1. Regulatory documentation and submission preparation2. Knowledge of global medical device regulations3. Technical writing and document management4. Attention to detail5. Project management and organizational skills6. Communication and stakeholder management7. Problem-solving and analytical thinkingAbout Company:Endo-Med Technologies Private Limited is one of the leading companies engaged in the development, manufacturing, and global distribution of minimally invasive medical devices in the fields of gastroenterology, pulmonology, and minimally invasive surgery, based in New Delhi, India.

Responsibilities

Key Responsibilities:

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

2. Maintain product licenses, registrations, and certifications

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

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

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

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

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

8. Support regulatory inspections and audits

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

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