Principal Regulatory Affairs Specialist, Labeling (SWICC)

📋 Description

• Establish regulatory requirements and guide product teams for labeling and UDI compliance across
• Lead regulatory labeling strategy discussions for medical device labels, IFUs, packaging, and
• Manage a large portfolio of labels and label versions, tracking change requests and ensuring
• Monitor FDA, EU, and international regulatory developments for labeling/UDI and assess impact
• Define labeling requirements per product family based on intended use, classification, claims, and
• Coordinate with international business units to implement country-specific labeling requirements

🎯 Requirements

• Bachelor's degree in a scientific, engineering, or related discipline
• At least 7 years of experience in medical device regulatory affairs, including 3 years in medical
• Professional experience in the medical device industry, preferably single-use consumables
• Expert knowledge of FDA 21 CFR Part 801 (labeling), 21 CFR Part 830 (UDI), and 21 CFR Part 820
• Strong understanding of EU MDR 2017/745, MDSAP, and ISO 13485
• Extensive knowledge of international labeling regulations (Europe, Canada, Australia, UK, Middle

🎁 Benefits

• Annual base salary range $120,160 - $150,000
• 15% Short-Term Incentive Plan (STIP)
• Health, dental, and vision insurance
• 401(k) retirement plan with company matching
• Paid time off
• Wellness initiatives and health assistance resources