Global Medical Device Labeling Specialist

Nextern; Osseo (MN); Sur place; USD 70 000 - 100 000; Plein temps

Avantages offerts par ce poste

Health care plan

Retirement plan

Paid time off

Birthday holiday

Wellness resources

Life insurance

Family leave

Disability coverage

Taco Thursdays

Résumé du poste

Nextern is seeking a Labeling Specialist to develop, validate, and implement label designs for finished medical devices. You’ll ensure labels meet risk management and regulatory requirements, and drive accuracy from design through printing and manufacturing.

You will lead labeling activities for new product launches and regulatory updates, coordinate verification, and maintain DHF and change controls. Strong detail orientation and familiarity with 21 CFR 820/ISO 13485 preferred.

Qualifications

• 3+ years of experience in a Labeling Specialist role.
• Experience with 21 CFR 820 and ISO 13485 quality systems.
• Understanding of ISO 14971 and risk management applied to product development.
• Familiarity with medical device labeling requirements.
• Experience with barcoding systems such as GS1 or HIBC-128.

Responsabilités

• Develop label designs across multiple programs as part of project teams.
• Coordinate and execute label verification activities.
• Support label print station qualifications.
• Review and approve design and process changes to label designs or processes.
• Lead labeling activities for new product launches and regulatory updates.
• Interface with label raw material and equipment suppliers; act as labeling SME.
• Draft labeling processes, guidelines, templates, and forms within the Quality System.
• Create and maintain label print artwork files and related processes.
• Maintain up-to-date Design History Files (DHF).
• Ensure batch-specific information is accurate across ERP/PLM systems.

Connaissances

Labeling experience

Attention to detail

Communication skills

Print verification

Formation

Degree in graphic design, communication, business, or equivalent

Outils

BarTender

GSI Data Hub

Windchill

Agile

Propel

Epicor

NetSuite

Description du poste

Nextern is seeking a Labeling Specialist to develop, validate, and implement label designs for finished medical devices. You’ll ensure labels meet risk management and regulatory requirements, and drive accuracy from design through printing and manufacturing.

You will lead labeling activities for new product launches and regulatory updates, coordinate verification, and maintain DHF and change controls. Strong detail orientation and familiarity with 21 CFR 820/ISO 13485 preferred.