QA/RA Executive – Medical Devices (CE & EU MDR)
Key Responsibilities:
- Preparation and maintenance of EU MDR (2017/745) Technical Documentation.
- Preparation and review of CER, PMS, PMCF, RMF, GSPR, SSCP, DoC, and Technical Files.
- Ensure compliance with ISO 13485, ISO 14971, EU MDR, and applicable regulatory requirements.
- Manage CAPA, Change Control, NCR, Deviations, and Internal Audits.
- Coordinate CE Marking activities and Notified Body audits.
- Support product registrations and regulatory submissions.
- Review labeling, IFU, validation reports, and quality documents.
- Monitor regulatory updates and maintain QMS documentation.
Required Knowledge & Expertise:
- CE Marking & EU MDR Documentation.
- Technical File (TF) Preparation.
- Clinical Evaluation Report (CER).
- Risk Management File (RMF) – ISO 14971.
- Post-Market Surveillance (PMS).
- Post-Market Clinical Follow-up (PMCF).
- General Safety & Performance Requirements (GSPR).
- Summary of Safety & Clinical Performance (SSCP).
- Declaration of Conformity (DoC).
- Quality Management System (QMS) – ISO 13485.
- Corrective & Preventive Action (CAPA).
- Non-Conformance Report (NCR).
- Change Control & Document Control.
- Internal & External Audit Management.
- UDI and EUDAMED requirements.
Qualification:
Bachelor's degree in Biomedical Engineering, Biotechnology, Pharmacy, Life Sciences, Regulatory Affairs, or related field.
Experience:
2–5 years of experience in Medical Device QA/RA with hands-on experience in CE Marking and EU MDR documentation.
Pay: ₹25,000.00 - ₹50,000.00 per month
Benefits:
- Health insurance
- Leave encashment
- Paid sick time
- Provident Fund
Work Location: In person
