Regulatory Labeling Specialist

Contract Position

Are you ready to take ownership of global medical device labeling strategy in a highly regulated environment? My client is seeking a Contract Regulatory Labeling Specialist to drive compliance, accuracy, and innovation across product labeling, packaging, and documentation. This is a high-impact role where your expertise will directly support patient safety, regulatory excellence, and operational success.

Location: Plymouth Meeting, PA

• 6–12+ month contract with strong potential for extension
• High-visibility role partnering across Regulatory, Quality, Operations & Manufacturing
• Opportunity to lead ISO 15223-1:2021 symbol implementation and UDI strategy
• Work on globally distributed medical devices under FDA & EU MDR

• Develop and execute global labeling strategies (FDA, EU MDR, international markets)
• Oversee labeling compliance across packaging, IFUs, and SDS
• Lead UDI and barcode implementation across product lines
• Review and approve labeling content, artwork, and technical documentation
• Establish labeling quality control procedures and governance standards
• Partner with suppliers and cross‑functional teams to ensure consistency and compliance
• Drive continuous improvement using production data, complaints, and regulatory updates

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or related field
• Strong knowledge of 21 CFR Part 801, EU MDR, ISO 13485, ISO 15223-1:2021
• Experience managing UDI requirements and barcode systems
• Skilled in reviewing IFUs, packaging artwork, and document control systems
• RAC certification or audit/inspection support experience preferred

We’d love to see your resume, but we can start a conversation. Send an email to , tell us why you’re interested, or feel free to email your resume. Please include Job#19756.