Executive Quality Assurance and Regulatory Affairs Specialist

21 hours ago

Vijayawada, Andhra Pradesh, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000

Job Title: Executive Quality Assurance and Regulatory Affairs Specialist

About the Role:

We are seeking a highly skilled Executive – Quality Assurance / Regulatory Affairs professional to join our esteemed client in the Medical Device Industry. As a key member of the team, you will be responsible for ensuring compliance with regulatory frameworks and industry standards.

Key Responsibilities:
  • Compliance Management
    • Ensure adherence to regulatory requirements such as ISO 13485, MDD, MDR, GMP, GDP, and QMS.
    • Coordinate with local authorities for required permissions and approvals.
  • Risk Management
    • Oversee risk management, clinical evaluation, and post-market surveillance (PMS) for Class I, II, and III medical devices.
  • Regulatory Submissions
    • Manage submissions and ensure timely approvals.
  • CAPA and Compliance
    • Handle Corrective and Preventive Actions (CAPA) to maintain compliance and continuous improvement.

Candidate Profile:

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

What We Offer:

A competitive compensation package that reflects your expertise and qualifications. We also offer opportunities for professional growth and development in a dynamic and supportive environment.

Contact Information:

Please submit your resume and cover letter to [insert contact information]. We look forward to hearing from you

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