Medical Labeling & Compliance Specialist

Actalent; Minneapolis (MN); Hybrid; USD 41,000 - 54,000; Full time

Benefits offered by this job

Hybrid work model

Health benefits

401(k) retirement plan

Life Insurance

Disability insurance

HSA

Job summary

Actalent is seeking a Labeling Specification Specialist in Minneapolis, MN, to create, review, and manage labeling content for medical products. You will coordinate UDI data in QMS Agile and contribute to continuous improvement of labeling processes and quality systems.

This role suits an established individual contributor who works independently on moderately complex projects, collaborates with cross‑functional teams, and ensures labeling meets medical and regulatory requirements globally.

Qualifications

• Experience with medical package labeling content creation and review.
• Experience with UDI data management in QMS Agile or similar systems.
• Strong proofreading skills with attention to detail.
• Experience with quality systems and CAPA activities.
• Knowledge of medical device regulatory labeling requirements.
• Experience supporting regulatory audits for labeling/documentation.
• Professional discipline through education and experience.

Responsibilities

• Create, review, and reproduce text and artwork required for labeling medical products.
• Ensure labeling art, film, and plate proofs comply with US and international requirements.
• Monitor changes in labeling regulations and update content accordingly.
• Review promotional materials to confirm data support and alignment with approved applications.
• Suggest improvements to labeling processes and quality systems for efficiency and compliance.
• Coordinate and maintain UDI data in QMS Agile with accurate data entry.
• Support CAPA, change control, and validation labeling tasks within quality systems.
• Assist with labeling/documentation audits, providing required evidence.
• Deliver and manage labeling projects from design through implementation.
• Collaborate with stakeholders to share status and input for decision making.
• Apply medical device regulatory knowledge to ensure global labeling compliance.
• Mentor entry-level labeling staff and support personnel.
• Recommend system/process improvements for labeling efficiency.
• Set objectives to meet project milestones and broader goals.

Skills

Labeling content

UDI data management

Proofreading

CAPA

Change control

Regulatory knowledge

Audit support

Independence

Communication

Advanced education

Education

University degree in a relevant field

Advanced degree

Tools

QMS Agile

Job description

Actalent is seeking a Labeling Specification Specialist in Minneapolis, MN, to create, review, and manage labeling content for medical products. You will coordinate UDI data in QMS Agile and contribute to continuous improvement of labeling processes and quality systems.

This role suits an established individual contributor who works independently on moderately complex projects, collaborates with cross‑functional teams, and ensures labeling meets medical and regulatory requirements globally.