Regulatory Affairs Associate

Experience : 2 to 5 years

Education : Bachelor's degree in Biomedical, Mechanical, or B.Pharm

We are looking for talented professionals for roles in Quality Assurance, Regulatory Affairs, and Documentation in the Medical Devices domain.

Skills & Requirements :

Minimum 3 years of experience in Medical Devices Regulatory Affairs, Quality Assurance, or Documentation

• Strong knowledge of global regulatory frameworks : FDA QSR, ISO 13485, EU MDR, IEC standards
• Experience in DHF assessment and remediation
• Familiarity with FDA 21 CFR Part 820.30 and ISO 13485 : 2016 design control requirements
• Documentation skills – validation reports, change control, deviation records
• Strong communication skills, both written and verbal