Manager Quality Assurance and Regulatory Affairs

Job Description

Manager Quality Assurance and Regulatory Affairs About 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. Show more Show less