Job Requirements
At Quest Global, it’s not just what we do but how and why we do it that makes us different. With over 25 years as an engineering services provider, we believe in the power of doing things differently to make the impossible possible. Our people are driven by the desire to make the world a better place—to make a positive difference that contributes to a brighter future. We bring together technologies and industries, alongside the contributions of diverse individuals who are empowered by an intentional workplace culture, to solve problems better and faster.
Overview
Quest Global is seeking an experienced Quality and Regulatory Lead with 10 – 15 years of experience in the medical devices industry to lead and oversee regulatory activities. In-depth understanding of medical device quality management system. This role requires solid technical and regulatory knowledge. They ensure compliance with global regulations, manage product approvals and guide the clients in meeting regulatory requirements throughout the product lifecycle.



Role requires strong understanding of medical device manufacturing process and quality systems.
Roles and Responsibilities
· Lead and mentor a team of quality and regulatory professionals, fostering a culture of excellence and continuous improvement
· Provide guidance on complex regulatory issues and training on new regulations
· Develop and execute global regulatory strategies to support product approvals and market access
· Conduct quality audits of R&D; and Manufacturing plant.
· Collaborate with cross-functional teams (R&D;, Quality, Marketing etc.) to ensure alignment of regulatory requirements with business goals of the client
· Manage interactions with regulatory authorities to facilitate timely approvals
· Ensure compliance with relevant standards and regulations, including ISO 13485, EU MDR, FDA 21 CFR 820, QMSR, ISO 14971, IEC 62304, IEC 62366 and other applicable country wise and global requirements
· Manage regulatory im

📌 Quality and Regulatory Lead (Chennai)
🏢 Quest Global
📍 Chennai