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Medical Device Compliance Expert

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Aligarh, Uttar Pradesh, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 25,00,000
Medical Device Quality Assurance and Regulatory Affairs Lead

We are seeking an accomplished professional to spearhead our efforts in ensuring the quality and regulatory compliance of medical devices.

This role entails overseeing the implementation of quality management systems, managing regulatory submissions, and ensuring timely approvals. The ideal candidate will possess a strong understanding of industry standards and regulations, including ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.

  • Key Responsibilities:
  • Develop and execute strategies for maintaining compliance with regulatory requirements
  • Coordinate with relevant authorities for obtaining necessary permissions and approvals
  • Oversee risk management, clinical evaluation, and post-market surveillance for medical devices
  • Manage regulatory submissions and ensure timely approval processes
  • Implement Corrective and Preventive Actions (CAPA) to maintain compliance and drive continuous improvement
  • Support audits, inspections, and ensure readiness for regulatory authority reviews

Candidate Profile:

  • Demonstrated expertise in quality systems and regulatory frameworks for medical devices
  • Hands-on experience with regulatory submissions, post-market surveillance, and risk management
  • Excellent knowledge of GMP, GDP, and ISO 13485 standards
  • Strong communication, documentation, and coordination skills