Regulatory Affairs Specialist

Overview
Develop, implement, and maintain Quality Management Systems (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable standards.

Conduct internal audits, CAPA (Corrective & Preventive Action), and risk assessments to ensure ongoing compliance.

Monitor production processes and verify adherence to SOPs, specifications, and quality standards.

Quality Control

Perform in-process inspections, final product testing, and release of products.

Review and approve batch records, test reports, and other QC documentation.

Manage calibration and preventive maintenance schedules for testing and measuring instruments.

Investigate non-conformities and implement corrective actions.

Regulatory Compliance

Ensure compliance with national and international medical device regulations (FDA, CDSCO, CE, ISO).

Support preparation of regulatory submissions (510(k), PMA, CE Marking, etc.).

Communicate with regulatory authorities to resolve compliance issues.

Process Improvement

Identify areas of process improvement to enhance product quality and operational efficiency.

Implement Lean Six Sigma/continuous improvement methodologies to reduce defects and improve productivity.

Supplier Quality Management

Conduct supplier audits and ensure raw material/component quality.

Collaborate with vendors for corrective actions and quality improvement initiatives.

Documentation & Reporting

Prepare and maintain technical files, Device Master Records (DMR), and Device History Records (DHR).

Maintain up-to-date documentation to support internal audits, external inspections, and certifications.

Generate quality reports and present trends to management for decision-making.

Required Skills & Knowledge

Strong understanding of QA/QC principles in the medical device industry.

Knowledge of ISO 13485, ISO 14971, GMP, and FDA 21 CFR Part 820.

Hands-on experience with quality audits, validation, and verification processes.

Familiarity with regulatory submissions and compliance requirements.

Excellent documentation, analytical, and problem-solving skills.

Ability to train and guide cross-functional teams on quality and compliance.

WhatsApp: +91 9266682964

Job Type: Full-time

Pay: ₹25,274.41 - ₹35,954.13 per month

Benefits:

• Health insurance

Work Location: In person