Senior Regulatory Compliance Specialist

2 days ago

Anantapur, Andhra Pradesh, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000
Quality Assurance Executive Job Description">

 

We are seeking a highly skilled Quality Assurance / Regulatory Affairs professional to join our esteemed organization in the Medical Device Industry.

Key Responsibilities:

  • Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS standards.
  • Coordinate with regulatory bodies to obtain required permissions and approvals.
  • Oversee risk management, clinical evaluation, and post-market surveillance (PMS) for Class I, II, and III medical devices.
  • Manage regulatory submissions and ensure timely approvals.
  • Handle Corrective and Preventive Actions (CAPA) to maintain compliance and continuous improvement.
  • Support audits, inspections, and ensure readiness for regulatory authority reviews.

Candidate Requirements:

  • Strong understanding of quality systems and regulatory frameworks for medical devices.
  • Hands-on experience with regulatory submissions, PMS, and risk management.
  • Excellent knowledge of GMP, GDP, and ISO 13485 standards.
  • Strong communication, documentation, and coordination skills.

Benefits:

  • Opportunity to work with a dynamic team in the medical device industry.
  • Chance to develop expertise in quality assurance and regulatory affairs.
  • Collaborative work environment with a focus on continuous improvement.

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