Regulatory Compliance Specialist

4 days ago


Ahmedabad, Gujarat, India Biotech Healthcare Full time

Job Summary

Biotech Healthcare is looking for a talented Regulatory Compliance Specialist to oversee our quality management activities and ensure adherence to regulatory requirements. This role requires strong expertise in quality assurance, QMS implementation, and regulatory compliance.

About the Job

  • Design, implement, and maintain a Quality Management System (QMS) framework that meets industry standards.
  • Oversee the approval process for Site Master Files, Validation Master Plans, Quality Manuals, and stability summary reports.
  • Conduct internal audits and self-inspections to assess compliance with quality standards and identify areas for improvement.

Responsibilities

  1. Quality Management System (QMS) Development: Develop and implement QMS processes, manage training initiatives, and drive projects related to quality and regulatory compliance.
  2. Compliance & Documentation: Ensure procedural compliance in handling Change Control Notices (CCN), deviations, market complaints, Out-of-Specification (OOS) issues, CAPA, and IPQA non-conformances.
  3. Audit & Risk Management: Lead internal audits and self-inspections to assess compliance with quality standards and identify areas for improvement.
  4. Training & Development: Identify training needs across departments and design comprehensive training programs on GMP, QMS, and regulatory compliance.

Requirements

  • Strong expertise in Quality Assurance, QMS implementation, and regulatory compliance.
  • Proficiency in managing quality projects, conducting internal audits, and performing gap analyses.
  • In-depth understanding of GMP, GDP, ISO 13485, and FDA regulations.
  • Ability to lead and manage cross-functional teams effectively.

About Us

We are committed to delivering high-quality medical devices that meet regulatory requirements. Our team values innovation, teamwork, and continuous improvement. If you are passionate about quality and regulatory compliance, join us in shaping the future of medical devices.



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