Regulatory Affairs Manager – Labeling

Role Overview

• Lead the end-to-end alignment of medical device labeling, packaging, and digital assets with evolving international regulations
• Oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements
• Manage the entire labeling lifecycle, including the creation, review, approval, and maintenance of all labeling content and artwork within a controlled Quality Management System
• Proactively monitor the global regulatory landscape for any new or revised labeling requirements
• Ensure all product labeling strictly adheres to global medical device regulations
• Lead and manage the implementation and maintenance of Unique Device Identification (UDI) requirements on all applicable label and packaging levels across global markets
• Act as the primary expert for all environmental and sustainability labeling requirements driven by global directives
• Ensure the correct application of environmental symbols and marks
• Act as a central hub for collaboration on all labeling matters

Requirements

• Bachelor’s degree in scientific, engineering, life sciences, or related field
• Minimum of 7-10 years of experience in a Regulatory Affairs role within the medical device industry
• Specific and demonstrated experience in global medical device labeling, including the creation and management of labeling content, IFUs, and artwork in a regulated environment
• Experience interpreting and applying environmental regulations (e.g., REACH, RoHS, WEEE, PPWR) to product labeling requirements is desired
• In-depth knowledge of labeling requirements for major global markets, including the US, EU, Canada, Japan, and Australia
• Exceptional Attention to Detail: A meticulous and precise approach to reviewing and managing complex information is absolutely essential for this role
• Ability to anticipate regulatory trends in labeling and develop proactive, long-term strategies to ensure compliance and mitigate risk
• Strong organizational and project management skills to manage multiple, concurrent labeling projects across different product lines and regions
• Proven ability to lead through influence, build consensus, and drive decisions across diverse, cross-functional teams
• Ability to apply risk management principles (ISO 14971) to the labeling process, identifying and mitigating risks associated with labeling errors, such as product recalls, shipping holds, or regulatory enforcement actions
• Excellent written and verbal communication skills, with the ability to clearly articulate complex labeling requirements to technical and non-technical audiences.

Benefits

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short
• and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs