Medical Labeling & Compliance Specialist

ACTalent; United States; Hybrid; USD 41,000 - 54,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) retirement plan

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off/Leave

Job summary

Actalent is seeking a Labeling Specification Specialist for a contract role based in Minneapolis, MN, offering a hybrid work arrangement. You will create, review, and manage labeling content for medical products, ensuring compliance with US and international regulations and corporate standards.

You will coordinate UDI data in the QMS Agile system, support quality systems activities including CAPA and change control, and collaborate with cross-functional teams to deliver accurate labeling on

Qualifications

• Experience with medical package labeling content creation and review.
• Experience with UDI data management within QMS Agile or similar systems.
• Strong proofreading with attention to detail for labeling and documentation.
• Experience with quality systems and CAPA including investigation and follow-up.
• Experience with change control and validation in a regulated environment.
• Knowledge of medical device regulatory labeling requirements.
• Experience supporting labeling and documentation audit activities.
• Ability to work independently on moderately complex projects.

Responsibilities

• Create, review, and reproduce labeling text and art for medical products.
• Ensure labeling artwork complies with US and international regulations.
• Monitor regulatory labeling changes and update content accordingly.
• Review promotional materials for data-supported claims and alignment with approvals.
• Suggest improvements to labeling processes and quality systems.
• Coordinate and maintain UDI data in QMS Agile.
• Support CAPA, change control, and validation tasks.
• Assist with labeling-related audits and provide required evidence.
• Lead labeling projects from design through implementation.
• Collaborate with stakeholders to share status and gather input.
• Apply regulatory knowledge to meet global labeling expectations.
• Mentor entry-level labeling staff.
• Recommend system/process enhancements for labeling efficiency.
• Set objectives to meet project milestones.

Skills

Medical labeling

UDI data management

Proofreading

Quality systems / CAPA

Change control

Regulatory labeling knowledge

Audit support for labeling

Cross-functional collaboration

Independent contributor

Communication skills

Education

University degree with 2+ years experience

Advanced degree (optional)

Tools

QMS Agile

Job description

Actalent is seeking a Labeling Specification Specialist for a contract role based in Minneapolis, MN, offering a hybrid work arrangement. You will create, review, and manage labeling content for medical products, ensuring compliance with US and international regulations and corporate standards.

You will coordinate UDI data in the QMS Agile system, support quality systems activities including CAPA and change control, and collaborate with cross-functional teams to deliver accurate labeling on