Regulatory Affairs Consultant

Job Role: Regulatory Affairs Consultant- Medical Devices

Experience: 2-4 years
Industry: Medical Devices / Healthcare Technology
Immediate joiners preferred

Role Summary

We are looking for a QA professional with experience in medical device software quality and regulatory compliance. The candidate should have strong knowledge of ISO 13485, EU MDR, and Software as a Medical Device (SaMD), with hands-on experience in quality management and software validation processes.

Required Skills

• Strong knowledge of ISO 13485
• Good understanding of MDR
• Experience with SaMD / medical device software
• Knowledge of software verification and validation (V&V)
• Familiarity with IEC 62304
• Experience with FDA 21 CFR Part 820 / QMSR
• Experience with regulatory submissions and medical device technical documentation.