Role Overview
We are seeking a detail-oriented ISO 13485 / Regulatory Affairs / cGMP Specialist to manage quality management systems, regulatory compliance, and manufacturing quality standards. The ideal candidate should have hands-on experience in ISO 13485, cGMP compliance, CAPA management, and technical documentation.
Key Responsibilities
Implement, maintain, and continuously improve the Quality Management System (QMS) in accordance with ISO 13485 standards.
Ensure compliance with cGMP regulations across manufacturing and operational processes.
Manage Corrective and Preventive Actions (CAPA) and monitor their effective implementation.
Plan and oversee validation and qualification activities.
Prepare, review, and maintain technical documentation, SOPs, quality records, and regulatory submissions.
Coordinate internal and external audits and support regulatory inspections.
Monitor changes in regulatory requirements and ensure organizational compliance.
Collaborate with cross-functional teams to maintain quality standards and drive continuous improvement initiatives.
Requirements
Experience working in ISO 13485, Regulatory Affairs, or cGMP environments.
Strong understanding of Quality Management Systems (QMS) and medical device regulations.
Hands-on experience in CAPA, validation activities, and regulatory documentation.
Excellent analytical, documentation, and problem-solving skills.
Ability to work effectively with cross-functional teams and regulatory authorities.
Preferred Qualifications
Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Biomedical Engineering, or a related field.
Certification or additional training in ISO 13485, Quality Management, or Regulatory Affairs is an added advantage.
Prior experience in medical devices, pharmaceuticals, or healthcare manufacturing is preferred.
Experience: Relevant experience in ISO 13485 / Regulatory Affairs / cGMP
Pay: ₹30,000.00 - ₹40,000.00 per month
Benefits:
- Paid time off
- Provident Fund
Work Location: In person
