Regulatory Affairs Manager - Labeling

Responsibilities

• Develop and implement a global labeling strategy ensuring compliance across all product lines
• Manage the entire labeling lifecycle from content development to final artwork approval
• Proactively monitor global regulatory changes and interpret their impact on labeling
• Ensure compliance with global medical device regulations regarding labeling content
• Lead and manage Unique Device Identification (UDI) requirements for labels and packaging globally
• Oversee environmental and sustainability labeling compliance driven by global directives
• Collaborate with cross-functional teams to ensure label accuracy and compliance

Qualifications

• Bachelor's degree in scientific, engineering, life sciences, or related field required; advanced degree or Regulatory Affairs Certification (RAC) is a plus
• 7-10 years of experience in a Regulatory Affairs role within the medical device industry
• Experience in global medical device labeling, including the creation and management of labeling content, Instructions for Use (IFUs), and artwork in a regulated environment
• Ability to interpret and apply environmental regulations (e.g., REACH, RoHS, WEEE, PPWR) to product labeling requirements
• In-depth knowledge of labeling requirements for major global markets, including the US, EU, Canada, Japan, and Australia

Pay

$105,100 – $150,100 annually

Schedule

Remote - US based candidates only, no visa sponsorship available