Senior QARA Executive

About the role

We are looking for a Quality Assurance & Regulatory Affairs (QARA) professional with 5+years of experience in the medical device industry. The candidate will support the maintenance of the Quality Management System (QMS), regulatory documentation, technical documentation, and compliance activities in accordance with applicable regulatory requirements and standards.

What you'll do

• Quality Management System (QMS)
• Maintain and support the company’s Quality Management System in compliance with International Organization for Standardization 13485 requirements
• Prepare, review, update, and maintain QMS documents including SOPs, procedures, work instructions, forms, and templates
• Ensure proper document and record control practices, including version control, traceability, archival, and obsolescence management
• Perform document release checks and proofreading before release to ensure correct document numbering, revision status, formatting, and completeness

What you need

• 5–9 yrs of experience
• Regulatory affairs
• ISO 9001
• Documentation
• Complaint handling
• SOP writing
• Internal audit
• B.Tech or B.E.

Good to have

• Medication administration