Regulatory Affairs job vacancy at Meerut in Golden Bird Healthcare

Regulatory Affairs
• Prepare and submit CDSCO MD-5 applications and manage communications with regulatory authorities.
• Compile, review, and maintain EU MDR CE Technical Files for medical devices.
• Manage product registration processes for DENTAKRIS products across multiple international markets.
• Monitor and ensure compliance with applicable regulatory requirements in target countries.

Quality Management System (QMS)
• Develop, implement, and maintain QMS documentation in compliance with ISO 13485 standards.
• Prepare and maintain SOPs, quality manuals, and process documentation for regulatory compliance.
• Support internal and external audits, including regulatory inspections.

Production Floor Quality Assurance
• Oversee QA procedures during manufacturing to ensure compliance with regulatory and company quality standards.
• Conduct in-process and final product quality checks.
• Investigate and document non-conformities and implement corrective actions.