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Are you a regulatory professional passionate about medical device compliance and quality systems? HCLTech, a global technology leader, is hiring a Regulatory Affairs Associate in Madurai, Tamil Nadu. This role is ideal for professionals with a background in Quality Assurance, Regulatory Affairs, or Documentation who want to contribute to global medical device projects ensuring safety, compliance, and innovation.
🔍 Key Responsibilities
- Support Regulatory Affairs and Quality Assurance activities for medical device projects.
- Prepare, review, and maintain technical documentation, including validation reports, DHF, change control, and deviation records.
- Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485:2016, EU MDR, and IEC standards.
- Participate in design control processes, including DHF assessment and remediation.
- Collaborate with cross-functional teams to ensure audit readiness and regulatory compliance.
🎓 Required Qualifications
- Education: Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or B.Pharm.
- Experience: 2–5 years (minimum 3 years preferred) in Regulatory Affairs, Quality Assurance, or Documentation within the Medical Devices domain.
- Skills:
- Strong understanding of global regulatory frameworks (FDA, ISO, EU MDR).
- Excellent documentation and communication skills.
- Familiarity with validation, change control, and deviation management.
💼 Benefits
- Competitive salary and annual performance bonuses.
- Opportunity to work on global medical device regulatory projects.
- Continuous learning and professional development programs.
- Inclusive and collaborative work culture at a Fortune 500 company.
📅 Application Process
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