Position: QA/RA Executive
Department: Quality Assurance & Regulatory Affairs
Experience: 2–3 Years
Salary: 30,000 – 40,000 per month
Industry: Medical Devices / Healthcare Manufacturing
Key Responsibilities:
- Preparation and maintenance of Device Master File (DMF) and technical documentation.
- Compilation of regulatory documents including:
- Essential Principles (EP) Checklist
- Regulatory Affairs (RA) Documentation
- Clinical Evaluation Report (CER)
- Design & Development Files
- Validation Documents
- Usability Engineering Files
- Ensure compliance with CDSCO, IMDRF, ISO 13485, and applicable regulatory requirements.
- Support product registration and regulatory submissions.
- Maintain Quality Management System (QMS) documentation as per ISO 13485 standards.
- Conduct internal audits and coordinate external audits.
- Prepare CAPA, NCR, change control, risk management, and validation records.
- Coordinate with cross-functional teams for regulatory and quality compliance activities.
- Monitor regulatory updates and implement necessary changes.
Requirements:
- Bachelor's degree in Biomedical Engineering, Life Sciences, Biotechnology, Pharmacy, or related field.
- 2–3 years of experience in QA/RA for Medical Devices.
- Hands-on experience in Device Master File preparation and regulatory documentation.
- Positive knowledge of CDSCO, IMDRF, and ISO 13485 requirements.
- Experience in handling ISO 13485 audits and QMS documentation.
- Strong documentation, communication, and analytical skills.
Preferred: Experience in medical device manufacturing and regulatory submissions.