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Senior Regulatory Compliance Specialist

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Job Title: Senior Regulatory Compliance SpecialistAbout the Role:

We are seeking a seasoned professional to lead our regulatory compliance efforts in the Medical Device Industry.

The ideal candidate will possess expertise in quality systems, regulatory frameworks, and industry standards for medical devices.

Key Responsibilities:

  • Ensure adherence to ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
  • Coordinate with regulatory authorities for obtaining necessary permissions and approvals.
  • Oversee risk management, clinical evaluation, and post-market surveillance 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 drive continuous improvement.
  • Support audits, inspections, and ensure readiness for regulatory authority reviews.

Candidate Profile:

  • 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.