Medical Device Regulatory Compliance Specialist

23 hours ago

Dindigul, Tamil Nadu, India beBeeCompliance Full time ₹ 30,00,000 - ₹ 50,00,000
Regulatory Compliance Specialist

We are seeking a highly skilled Regulatory Compliance Specialist to join our team. The successful candidate will have strong knowledge of quality systems and regulatory frameworks for medical devices.

About the Role:
  • This position requires ensuring compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
  • The role involves coordinating with local FDA and CDSCO for obtaining required permissions and approvals.
  • Responsibilities include overseeing risk management, clinical evaluation, and post-market surveillance (PMS) for Class Is, II, and Class III medical devices.
  • The successful candidate will manage regulatory submissions and ensure timely approvals.
  • Corrective and Preventive Actions (CAPA) will be handled to maintain compliance and continuous improvement.
  • The specialist will support audits, inspections, and ensure readiness for regulatory authority reviews.
Key Qualifications:
  • A strong understanding of quality systems and regulatory frameworks for medical devices is essential.
  • Hands-on experience with regulatory submissions, PMS, and risk management is required.
  • Excellent knowledge of GMP, GDP, and ISO 13485 standards is necessary.
  • Strong communication, documentation, and coordination skills are expected.
Benefits:
  • This role offers a unique opportunity to work in the Medical Device Industry.
  • The successful candidate will have the chance to develop their career in a dynamic and growing field.
  • Ongoing training and professional development opportunities will be provided.
About Us:

We are a reputable organization in the Medical Device Industry. Our mission is to provide high-quality products and services that meet the needs of our clients.

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