Biomedical Engineer, Hospital Working jobs in Rohini, Delhi, Delhi

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