Global Medical Device Labeling Expert

EXALTA; Bethlehem (Northampton County); On-site; USD 90,000 - 130,000; Full time

Job summary

EXALTA seeks a Subject Matter Expert in global medical device labeling, regulations and requirements. The role plans, develops and executes labeling documentation and product labeling, ensuring compliance with company policy and procedures to safeguard patient safety.

The specialist will support internal and external audits, translate labeling content as needed, and collaborate with cross-functional teams to manage GTIN and regulatory submissions in a fast-paced environment.

Qualifications

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

Responsibilities

• Develops and processes labeling documentation following company procedures.
• Ensures labeling aligns with global regulations and standards.
• Supports GTIN allocation with cross-functional teams.
• Assists with GUDID and EUDAMED data maintenance and submissions.
• Investigates and resolves labeling non-conformities from audits.
• Supports labeling process audits and maintains compliance.

Skills

Medical Terminology

Regulatory knowledge

Communication skills

Project management

Problem solving

Attention to detail

Education

BA/BS in scientific discipline

Job description

EXALTA seeks a Subject Matter Expert in global medical device labeling, regulations and requirements. The role plans, develops and executes labeling documentation and product labeling, ensuring compliance with company policy and procedures to safeguard patient safety.

The specialist will support internal and external audits, translate labeling content as needed, and collaborate with cross-functional teams to manage GTIN and regulatory submissions in a fast-paced environment.