Medical Device Labeling Specialist

Who We Are

ABOUT ENOVIS

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement global talent and innovation the Companys extensive range of products services and integrated technologies fuels active lifestyles in orthopedics and more information about Enovis please visit .

What Youll Do

At Enovis we pay attention to the details. We embrace collaboration with our partners and patients and take pride in the pursuit of scientific excellence with the goal of transforming medical technology as we know it.

Because thats how we change the lives of patients for the better. And thats how we create better together. Why work at Enovis See for yourself.

As a key member of the Manufacturing Engineering team you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

Job Title:

Medical Device Labeling Specialist

Reports To:

Manager Manufacturing Engineering

Location:

Houston Plant

Business Unit Description:

Foot and Ankle

High-Level Position Summary:

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.

Key Responsibilities: The following are the primary duties and responsibilities of this role. Other related duties may be assigned to meet the business need.

• 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.

Minimum Basic Qualifications:

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required.

• 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

Work environment Physical demands:

• Ability to sit and stand for long periods of time.

• Ability to work in an office and manufacturing environment as required.

• Occasional travel may be required.

Desired Characteristics:

• Bachelors 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

Currently Enovis does not provide sponsorship for employment visas (e.g. H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States both now and in the future without requiring sponsorship.

Creating better together. Its the Enovis purpose and its what drives us and empowers us every day on a global scale. We know that the power to create better for our customers our team members and our shareholders begins with having the best team pursuing common goals operating at the highest levels and delivering extraordinary outcomes.

What does creating better together mean to us at Enovis Discover the why behind our purpose values and behaviors:

Our Enovis Purpose Values and Behaviors on Vimeo

We offer a comprehensive benefits package that includes:

• Medical Insurance

• Dental Insurance

• Vision Insurance

• Spending and Savings Accounts

• 401(k) Plan

• Vacation Sick Leave and Holidays

• Income Protection Plans

• Discounted Insurance Rates

• Legal Services

EQUAL EMPLOYMENT OPPORTUNITY
Enovis provides equal employment opportunities based on merit experience and other work-related criteria without regard to race color ethnicity religion national origin sex age pregnancy disability veteran status or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.