RegTrac, a fast-growing global consulting firm in medical device regulatory and quality compliance, is hiring a Medical Devices QMS – EU MDR QA Associate for its Chennai (Hybrid) location. This opportunity is ideal for pharmacy, life science, biomedical, and engineering graduates looking to build a strong career in EU MDR, ISO 13485 Quality Management Systems, and regulated medical device environments.
This role offers hands-on exposure to EU MDR compliance, technical documentation, post-market surveillance (PMS), CAPA, audits, and Notified Body interactions, making it a high-value early-career opportunity in the medical devices QA domain.
Job Details
- Job Title: QA Associate – Medical Device QMS (EU MDR)
- Company: RegTrac
- Location: Chennai, Tamil Nadu, India (Hybrid)
- Employment Type: Full-time
- Experience Required: 1–3 years
- Industry: Medical Devices, Regulatory Affairs, Quality Assurance
Key Responsibilities
Quality Management System (QMS)
- Support and maintain ISO 13485-compliant QMS aligned with EU MDR
- Manage document control (creation, review, approval, versioning, archiving)
- Maintain audit-ready quality records
- Support change control and impact assessments
EU MDR & Regulatory Support
- Assist with EU MDR compliance activities
- Support technical documentation and GSPR mapping
- Contribute to Post-Market Surveillance (PMS) documentation
- Assist in Notified Body audits and surveillance activities
Quality Operations
- Support CAPA, deviations, and non-conformance management
- Assist with internal audits and follow-up actions
- Support supplier quality documentation
- Maintain training records and QMS training coordination
Post-Market & Vigilance
- Support PMS data collection and trending
- Assist with complaint handling documentation
- Support EU MDR vigilance reporting (as applicable)
Required Qualifications
- Postgraduate degree in Pharmacy, Life Sciences, Biomedical Engineering, Engineering, or related field
- 1–3 years of experience in medical device QA or regulated environments
- Working knowledge of:
- EU MDR / IVDR
- ISO 13485, US FDA QMSR, MDSAP
- CAPA, audits, document control
- Experience with electronic QMS (eQMS)
- Strong documentation and attention to detail
Desirable Skills
- Exposure to Notified Body audits
- Experience supporting technical files
- Knowledge of ISO 14971 (Risk Management)
- Understanding of PMS and vigilance requirements
Why Join RegTrac?
- Work with experienced global regulatory and quality professionals
- Strong exposure to EU MDR and international medical device regulations
- Supportive, collaborative, and learning-driven culture
- Opportunity to directly contribute to patient safety and compliance
- Clear career growth path in medical device QA & regulatory affairs
Salary (Expected)
💰 ₹4,00,000 – ₹7,00,000 per annum (CTC)
(Salary may vary based on experience, skills, and interview performance)
How to Apply
