Medical Device Labeling Specialist

Enovis•Houston, TX

20h

About The Position

We are seeking a skilled and experienced Medical Device Labeling Specialist to join our team. The Medical Device Labeling Specialist supports company goals by developing, maintaining, and controlling medical device labeling to ensure accuracy, compliance, and manufacturability throughout the product lifecycle. This role serves as a primary point of coordination for labeling content across multiple systems and stakeholders, supporting new product introductions (NPI), sustaining operations, labeling change management, and select manufacturing and continuous improvement initiatives. The specialist works closely with Regulatory Affairs, Quality, Manufacturing, Supply Chain, and Engineering to reduce labeling risk and ensure consistent execution in a regulated manufacturing environment.

Requirements

3+ years of experience supporting medical device labeling, quality, regulatory, or manufacturing operations
Working knowledge of medical device labeling regulations and standards (FDA, EU MDR, ISO, UDI)
Strong attention to detail, organizational skills, and ability to work effectively in a regulated manufacturing environment
Ability to sit and stand for long periods of time.
Ability to work in an office and manufacturing environment as required.

Nice To Haves

Bachelor’s degree in a technical field (e.g., Engineering, Life Sciences)
Experience supporting NPI and global product launches in a regulated manufacturing environment
Experience with labeling software and multi-system labeling workflows (e.g., ERP, MES, QMS)
Familiarity with design control, risk management, and formal change control processes
Experience supporting internal and external audits or regulatory inspections

Responsibilities

Develop, maintain, and support medical device labeling, including primary, secondary, packaging, and patient-facing labels
Ensure labeling compliance with applicable global regulations and standards (e.g., FDA 21 CFR Part 801, EU MDR, ISO 15223-1, UDI requirements)
Serve as the primary point of coordination for labeling content, ownership, and change control across function, systems, and projects.
Manage label content, formatting, symbols, barcodes, and translations for domestic and international markets
Perform impact assessments and support formal change control activities related to labeling updates and revisions
Ensure labeling is manufacturing-ready, including printability, inspection, reprint, and deviation considerations
Troubleshoot labeling issues in manufacturing, packaging, and distribution environments, including support of investigations, nonconformances, and CAPAs
Support UDI implementation, barcode verification, and traceability requirements
Support continuous improvement efforts related to labeling systems, templates, and workflows to reduce risk and variability
Provide support to manufacturing and engineering team initiatives as needed, including labeling, NPI, and process improvement efforts.