Leonid Group Ltd

The Product Stewardship & Regulatory Compliance Specialist is responsible for ensuring compliance with U.S. and global medical device regulations and managing product material and substance compliance across the device portfolio. The role focuses on product composition control, restricted substances management, regulatory reporting, and lifecycle product stewardship from design through post-market. This role supports compliance with FDA requirements and ISO-based Quality Management Systems, ensuring accurate material data, safe product design, and regulatory readiness across global markets. Key Responsibilities Ensure compliance with FDA medical device regulations (21 CFR Part 820 / QMSR transition) and applicable standards such as ISO 13485 and ISO 10993 Manage material and substance compliance data, including restricted substances, supplier declarations, and product composition records Support R&D, engineering, procurement, and quality teams in selecting compliant and...