Job Title: Regulatory Affairs & Quality Assurance Executive
Industry: Medical Devices & Equipment
Job Summary
we are looking for a detail-oriented and experienced Regulatory Affairs & Quality Assurance to ensure compliance of medical devices and drug products with national and international regulatory requirements. The candidate will be responsible for regulatory submissions, quality documentation, QMS implementation, and maintaining compliance with applicable standards such as EU MDR and ISO 13485.
Key Responsibilities
Regulatory Affairs:
- Manage regulatory compliance activities for medical devices.
- Prepare, review, and maintain regulatory documents, technical files, dossiers, and submissions.
- Ensure compliance with EU MDR, FDA regulations, and other applicable regulatory requirements.
- Support regulatory audits, inspections, and product registration activities.
- Maintain regulatory records and track regulatory updates.
Quality Assurance:
- Implement and maintain Quality Management System (QMS) as per ISO 13485 and ISO 9001 standards.
- Prepare and review SOPs, quality documents, and records.
- Handle CAPA, change control, deviation, and non-conformance management.
- Support internal and external quality audits.
- Ensure continuous improvement in quality processes.
Required Skills :
- Experience in Regulatory Affairs / Quality Assurance in Medical Devices.
- Knowledge of EU MDR, FDA regulations, ISO 13485, and ISO 9001.
- Good documentation and reporting skills.
- Strong communication and computer skills.
- Ability to manage regulatory and quality documentation independently.
Pay: ₹25,000.00 - ₹40,000.00 per month
Benefits:
Work Location: In person
