*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
