Job Title

Manager Quality Assurance and Regulatory AffairsAbout Us:Our Client Company are innovative leaders in the life sciences and in vitro diagnostics (IVD) sectors, specializing in advanced R&D, engineering, and manufacturing. Our facilities in the USA and India are ISO 13485-certified and fully compliant with US FDA regulations. With a robust international distributor network, we are dedicated to delivering cutting-edge diagnostic solutions that enhance global healthcare.Position Summary:We seek a proactive, experienced Quality Assurance & Regulatory Affairs (QA/RA) Manager to lead and ensure regulatory compliance and product quality for our life sciences and IVD product lines. The QA/RA Manager will play a pivotal role in meeting global regulatory standards, maintaining excellence throughout the product lifecycle, and providing essential support to our international distributor network.Key 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. Develop and implement effective QA/RA strategies for new and existing products. Manage global regulatory submissions including FDA 510(k), CE marking, 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.