Senior Medical Device Quality Assurance and Regulatory Specialist

24 hours ago


Tirupati, Andhra Pradesh, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000

Job Overview

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We are seeking an experienced Quality Assurance and Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong understanding of quality systems and regulatory frameworks for medical devices, as well as hands-on experience with regulatory submissions, post-market surveillance, and risk management.

Main Responsibilities

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  • Ensure compliance with quality standards including ISO 13485, MDD, and MDR to maintain a robust quality management system.">
  • Coordinate regulatory submissions and obtain necessary permissions and approvals from local authorities like FDA and CDSCO.">
  • Oversee risk management, clinical evaluation, and post-market surveillance for Class I, II, and III medical devices to ensure safety and efficacy.">
  • Manage corrective and preventive actions (CAPA) to maintain compliance and continuous improvement in quality processes.">
  • Support audits and inspections to ensure readiness for regulatory authority reviews.">
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Key Requirements

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  • Strong understanding of 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.">
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About the Role

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This is an exciting opportunity for a motivated and detail-oriented professional to make a meaningful contribution to our organization. If you are passionate about quality assurance and regulatory affairs, we encourage you to apply.



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