Global Medical Device Labeling Specialist

Exalta Group; Marquette (MI); On-site; USD 65,000 - 90,000; Full time

Job summary

Exalta Group in Marquette, MI seeks a Labeling Specialist to serve as subject matter expert in global medical device labeling, regulations and requirements, planning, developing and executing labeling documentation and product labeling.

You will ensure compliance with 21 CFR 820, MDR and ISO 13485, support GTIN allocations and GUDID/EUDAMED data, and assist in audits. Collaboration across cross-functional teams is essential.

Qualifications

• 2+ years of regulatory affairs or quality systems experience.
• BA/BS in a scientific discipline or equivalent experience.
• Experience with labeling regulations and document development is preferred.

Responsibilities

• Develops, edits, reviews and processes labeling documentation and medical device labeling following company procedures, including translation management.
• Ensures labeling documentation and labeling is professional, readable and compliant with applicable global regulations, directives, standards and guidance requirements.
• Works with cross functional project teams to perform GTIN allocation.
• Assist with GUDID and EUDAMED data maintenance and submissions.
• Investigate and resolve internal audit findings and external audit findings related to labeling non-conformities.
• Support internal and external audits specific to labeling processes and released labeling documentation and labels.
• Monitor global labeling regulations, directives, standards and guidance requirements for changes in labeling requirements, perform gap assessments where required.
• Write and update standard operating procedures and work instructions to maintain compliance with applicable labeling regulations, directives, guidance, and standards.

Skills

Medical Terminology

Regulatory Knowledge

Communication Skills

Project Management

Problem Solving

Attention to Detail

Cross-functional Collaboration

Work Under Pressure

Education

BA/BS in scientific discipline or equivalent experience

Job description

Exalta Group in Marquette, MI seeks a Labeling Specialist to serve as subject matter expert in global medical device labeling, regulations and requirements, planning, developing and executing labeling documentation and product labeling.

You will ensure compliance with 21 CFR 820, MDR and ISO 13485, support GTIN allocations and GUDID/EUDAMED data, and assist in audits. Collaboration across cross-functional teams is essential.