Overview

Quest Global is seeking an experienced Quality and Regulatory Lead with 8 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 robust 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 impact assessments for design and manufacturing changes

• Oversee regulatory activities for product updates, labeling changes and post-market surveillance

• Monitor and interpret evolving regulations to anticipate and manage changes

• Ensure compliance of verification, validation and testing protocols with applicable standards

We are known for our extraordinary people who make the impossible possible every day. Questians are driven by hunger, humility, and aspiration. We believe that our company culture is the key to our ability to make a true difference in every

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