Job Description

Key Responsibilities:

Maintain and continually improve the Quality Management System (QMS) in accordance with ISO 13485 and applicable international and local regulatory requirements. Conduct and oversee internal quality audits, assess compliance, and identify areas for improvement. Manage non-conformances, and implement corrective and preventive actions (CAPAs) to ensure timely and effective resolution. Coordinate and prepare for external audits, including inspections by regulatory authorities and other customer audits. Review and approve quality-related documentation, including Standard Operating Procedures (SOPs), work instructions, and quality records. Prepare, compile, and review regulatory dossiers in accordance with country-specific guidelines and CTD (Common Technical Document) format. Handle submissions through applicable regulatory portals for product registrations, Test Licenses, Manufacturing Licenses, and other required authorizations. Review all regulatory documents for accuracy, completeness, and compliance with applicable guidelines. Ensure timely dispatch of tender and regulatory documents to relevant authorities or partners to meet submission deadlines.

Qualifications:

B.Tech in any Engineering discipline. Candidates with prior experience in Quality Assurance (QA) or Regulatory Affairs (RA) will be preferred.
Job Type: Full-time

Pay: From ?12,000.00 per month

Work Location: In person