Manager, Regulatory Labeling and Operations

Responsibilities

• Lead all labeling activities for Neuromodulation product portfolios
• Manage EU MDR compliance for labeling, including gap assessments
• Define global labeling strategies aligned with regulatory requirements
• Oversee vendor management and localization processes
• Ensure consistency in labeling documentation including IFUs and packaging
• Cook up the UDI strategy and its implementation across therapies
• Verify labeling accuracy and integration within design control

Qualifications

• 8+ years in medical device labeling or regulatory affairs
• Experience with Class III medical implantable systems
• Strong knowledge of FDA regulations, EU MDR, and global labeling requirements
• Familiarity with tools like MadCap Flare and Adobe Suite
• Proficiency in localization and translation management
• Skilled in managing labeling lifecycle and document control processes
• Proven project leadership and cross-functional collaboration abilities

Pay

$120,000 – $145,000 annually

Schedule

Remote - US based candidates only, no visa sponsorship available

Benefits

• Health benefits - Medical, Dental, Vision
• Personal and Vacation Time
• Retirement & Savings Plan (401K)
• Employee Stock Purchase Plan
• Training & Education Assistance
• Bonus
• Referral Program
• Employee Recognition Program
• Flexible Work Schedules

Company Information

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.