Senior Regulatory Compliance Specialist

3 days ago


Hyderabad, Telangana, India beBeeQualityAssurance Full time ₹ 8,00,000 - ₹ 12,00,000

Job Overview

We are seeking a Quality Assurance Specialist to join our team. In this role, you will be responsible for implementing and maintaining a Quality Management System (QMS) that ensures our products meet quality, safety, and regulatory standards.

Key Responsibilities:

  • Implementing and maintaining a QMS in accordance with ISO standards
  • Ensuring regulatory compliance by identifying, interpreting, and adhering to relevant medical device regulations
  • Creating, reviewing, and controlling technical files, regulatory submissions, and quality agreements
  • Providing QA/RA input and support for design and development activities
  • Participating in risk management activities throughout the product life cycle
  • Monitoring device performance in the market and investigating customer complaints and non-conformity
  • Supporting the management of supplier quality and compliance

Requirements:

  • Regulatory expertise with deep knowledge of global medical device regulations and standards
  • Problem-solving and attention to detail with ability to interpret regulations and resolve issues
  • Strong communication skills with ability to coordinate with internal departments and external stakeholders
  • Bachelor's degree in a relevant field such as engineering, life sciences, or a related technical discipline
  • Previous experience in QA/RA within the medical device industry is an advantage

Why You'll Love This Role

This is a unique opportunity to work in a dynamic and fast-paced environment where you can make a real impact on our products and services. As a Quality Assurance Specialist, you will have the chance to develop your skills and expertise in a rapidly evolving industry.



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