Manager – Quality and Regulatory Assurance

2 days ago

Hyderabad, Telangana, India Omicsveu Full time ₹ 12,00,000 - ₹ 36,00,000 per year

*Summary*

We are seeking a proactive and experienced Quality Assurance & Regulatory Affairs (QA/RA) Manager to lead and uphold regulatory compliance and product quality across our life sciences and IVD product lines. The ideal candidate will have a strong understanding of ISO 13485, FDA QSR/QMSR, EU IVDR, and CDSCO regulatory frameworks, and experience with FDA 510(k) submissions, EU Technical Files, and IVDR transition strategies.

*Responsibilities*


• Ensure continuous compliance with ISO 13485, US FDA QMSR, EU IVDR, and other applicable global regulations.


• Lead, develop, and maintain a comprehensive Quality Management System (QMS) covering product development, manufacturing, and distribution.


• Manage global regulatory submissions including FDA 510(k), IVDR transition project, and international product registrations.


• Provide regulatory guidance during product design, development, validation, and change management processes.


• Conduct internal audits and supplier audits; support external regulatory inspections and audits by notified bodies.


• Act as primary QA/RA liaison for the global distributor network, ensuring timely registration support and addressing compliance inquiries.


• Collaborate with cross-functional teams at USA and India locations to integrate quality and regulatory objectives with business goals.


• Stay informed about emerging trends in AI and digital health, and ensures alignment of quality and regulatory strategies with evolving technologies.

*Requirements*


• Bachelor's or Master's degree in any Science discipline (e.g., Life Sciences, Chemistry, Biotech, Biomedical Engineering).


• 5 to 8 years of professional experience in Quality Assurance / Regulatory Affairs in the medical device or IVD industry.


• Strong understanding of ISO 13485, FDA QSR/QMSR, EU IVDR, and CDSCO regulatory frameworks.


• Proven experience with FDA 510(k) submissions, EU Technical Files, and IVDR transition strategies.


• Strong analytical, organizational, and communication skills, with the ability to collaborate across international teams.


• Demonstrated ability to manage multiple priorities in a fast-paced, regulated environment.


• High adaptability to new technologies and rapidly changing regulatory environments.


• Experience using AI platforms to support quality, documentation, or regulatory functions is a strong advantage.

Requirements

  • Bachelor's or Master's degree in any Science discipline (e.g., Life Sciences, Chemistry, Biotech, Biomedical Engineering).
  • 5 to 8 years of professional experience in Quality Assurance / Regulatory Affairs in the medical device or IVD industry.
  • Strong understanding of ISO 13485, FDA QSR/QMSR, EU IVDR, and CDSCO regulatory frameworks.
  • Proven experience with FDA 510(k) submissions, EU Technical Files, and IVDR transition strategies.
  • Strong analytical, organizational, and communication skills, with the ability to collaborate across international teams.
  • Demonstrated ability to manage multiple priorities in a fast-paced, regulated environment.
  • High adaptability to new technologies and rapidly changing regulatory environments.
  • Experience using AI platforms to support quality, documentation, or regulatory functions is a strong advantage

Benefits

  • 5 day work week
  • Free Transport Facility
  • Free Insurance Coverage for family
  • PTO & Time Off
  • Flat Organization Structure

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