Global Medical Device Labeling Specialist

Exalta Group; Hanover Township (Luzerne County); On-site; USD 70,000 - 90,000; Full time

Job summary

Exalta Group in Bethlehem, PA is seeking a Labeling Specialist who will be the subject matter expert for global medical device labeling, regulations and requirements, planning, developing and executing labeling documentation. The Specialist will ensure adherence to company policy and procedures and will assist in maintaining quality control processes.

You will collaborate with cross‑functional teams to manage GTIN allocation, GUDID/EUDAMED submissions and maintain SOPs to stay compliant with 21

Qualifications

• Minimum of 2 years experience in regulatory affairs or quality systems.
• BA/BS in scientific discipline or equivalent experience.

Responsibilities

• Develops, edits, reviews and processes labeling documentation and medical device labeling following company procedures, including translation management.
• 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

Regulations & guidelines

Communication skills

Attention to detail

Cross-functional collaboration

Education

BA/BS in scientific discipline

Job description

Exalta Group in Bethlehem, PA is seeking a Labeling Specialist who will be the subject matter expert for global medical device labeling, regulations and requirements, planning, developing and executing labeling documentation. The Specialist will ensure adherence to company policy and procedures and will assist in maintaining quality control processes.

You will collaborate with cross‑functional teams to manage GTIN allocation, GUDID/EUDAMED submissions and maintain SOPs to stay compliant with 21