Quality Assurance Regulatory Lead

4 days ago


Bengaluru, Karnataka, India Dozee Full time

Job Overview

We are seeking a highly motivated Quality Assurance Regulatory Lead to join our Quality Assurance team at Dozee. As a key member of our Quality Assurance department, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.

About the Role

This is a fantastic opportunity for an experienced professional to leverage their knowledge and expertise in medical device regulation to drive quality and compliance within our organization. The successful candidate will have a strong background in regulatory affairs, excellent analytical skills, and the ability to communicate complex information effectively.

Responsibilities

  • Leverage knowledge and expertise in medical device regulation to drive quality and compliance within the organization.
  • Develop and implement regulatory strategies for maintaining compliance with established standards like IEC 60601, IEC 62304, US FDA, and CE Marking.
  • Collaborate with cross-functional teams to ensure quality and regulatory requirements are successfully implemented and maintained.
  • Provide guidance to the team on interpreting regulatory requirements for various life-cycle stages of projects.
  • Drive good documentation practices and ensure adherence to standard processes.

Requirements

  • B.Tech degree in a relevant field.
  • A minimum of 3-5 years of experience in medical device regulation.
  • Experience with international medical device regulatory approvals and submissions.
  • Demonstrated knowledge of US FDA, EU MDR, ISO 13485 Quality Management System, and ISO 14971 Risk Management for Medical Devices.
  • Ability to analyze and interpret standards, technical procedures, professional journals, and governmental guidance and regulation documents.

What We Offer

The salary range for this position is $120,000 - $180,000 per year, depending on qualifications and experience. We offer a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.



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