Product Stewardship & Regulatory Compliance Specialist; Medical Devices

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.

• 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 safe materials
• Assess regulatory impact of material changes, supplier updates, and product design modifications
• Maintain and improve product compliance databases and PLM/QMS systems to ensure data accuracy and traceability
• Respond to internal and external requests for material compliance and substance information (customers, audits, regulators)
• Support FDA audits, inspections, and technical documentation readiness

• Bachelor’s degree in Chemistry, Materials Science, Biomedical Engineering, or related field
• 5+ years’ experience in medical device regulatory compliance, product stewardship, or materials management
• Strong knowledge of FDA regulations and ISO 13485 environments
• Experience with material compliance systems, PLM tools, or substance tracking databases
• Strong cross‑functional communication skills and attention to detail

• Experience with FDA submissions or audits (e.g., 510(k))
• Knowledge of ISO 10993 biocompatibility requirements
• Exposure to global regulatory frameworks (EU MDR, UKCA)
• Regulatory Affairs or Quality certifications (e.g., RAC, CQE)