Medical Labeling Specialist - Hybrid & Regulatory

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

Benefits offered by this job

Medical, dental & vision

401(k) retirement plan

Life Insurance

Disability benefits

HSA

Paid time off

Job summary

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

The role suits an experienced individual contributor who works independently on moderately complex projects, collaborates with cross-functional teams, and delivers accurate labeling materials

Qualifications

• Experience with medical package labeling, including creation and review of labeling content.
• Experience with UDI data management in QMS Agile or similar systems.
• Strong proofreading skills with attention to detail for reviewing labels and related documentation.
• Experience with quality systems and CAPA, including investigation and documentation.
• Experience with change control and validation in a regulated environment.
• Knowledge of medical device regulatory labeling requirements.

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 labeling regulations and incorporate updates into labeling content and processes.
• Review promotional materials to confirm data support and alignment with approvals.
• Coordinate and maintain UDI data within QMS Agile.
• Support quality systems activities including CAPA, change control, and validation labeling tasks.

Skills

Labeling content

UDI management

Quality systems

CAPA

Regulatory knowledge

Audit support

Tools

QMS Agile

Job description

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

The role suits an experienced individual contributor who works independently on moderately complex projects, collaborates with cross-functional teams, and delivers accurate labeling materials