Regulatory Affairs Associate

4 weeks ago

Madurai, India HCLTech Full time

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

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