Remote Global Labeling & UDI Lead – Medical Devices

Getinge Group; Lansing (MI); Remote; USD 120,000 - 150,000; Full time

Benefits offered by this job

Health, Dental & Vision insurance

401k with company match

Paid time off

Tuition reimbursement

15% STIP (bonus)

Job summary

Getinge is hiring a Principal Regulatory Affairs Specialist, Labeling (SWICC) in Lansing, MI. The role leads medical device labeling strategy, owns global labeling requirements, and ensures regulatory compliance across US, EU, and rest of world.

You will work with R&D, Quality, Marketing and Product Management on labeling and UDI programs. The position requires extensive experience in FDA/EU labeling regulations, PLM systems, and a high-volume labeling environment.

Qualifications

• Expert knowledge of labeling, PLM and change control, and MS Office applications (Word, Excel).
• Minimum 7 years of medical device regulatory affairs experience, including at least 3 years supporting medical device labeling.
• Experience with international labeling requirements (FDA, EU MDR, ISO 13485) and UDI procedures.

Responsibilities

• Leads regulatory labeling strategy discussions and serves as the regulatory subject matter expert for medical device labeling for SWICC consumables.
• Manages a high volume of labels and label versions across SWICC consumables, tracking changes and guiding cross-functional teams.
• Owns regulatory intelligence for labeling: monitors labeling and UDI requirements worldwide and communicates changes to R&D, Quality, Marketing and Product Management.
• Serves as the global labeling expert for SWICC consumables with international BU collaboration to meet country-specific requirements.
• Maintains awareness of labeling language and symbol requirements by region (EU, Canada, Australia, UK, etc.).
• Assesses regulatory changes against labeling and documents impact and recommends changes.
• Defines labeling requirements for each SWICC product family based on intended use and markets US, EU and rest of world.
• Develops/reviews labeling content and packaging for regulatory compliance, including translations and e-labeling.
• Provides guidance on GUDID/EUDAMED data submissions and lifecycle management for SWICC consumables.
• Supports PLM changes and risk management with labeling input and regulatory assessments.
• Delivers training on labeling and UDI requirements to cross-functional teams.
• Reviews translations and artwork for regulatory compliance prior to release.

Skills

Labeling knowledge

Regulatory affairs

Change control

FDA 21 CFR Part 801

UDI requirements

MS Office (Word, Excel)

Education

Bachelor's degree in a scientific, engineering or related field

Tools

PLM systems

Job description

Getinge is hiring a Principal Regulatory Affairs Specialist, Labeling (SWICC) in Lansing, MI. The role leads medical device labeling strategy, owns global labeling requirements, and ensures regulatory compliance across US, EU, and rest of world.

You will work with R&D, Quality, Marketing and Product Management on labeling and UDI programs. The position requires extensive experience in FDA/EU labeling regulations, PLM systems, and a high-volume labeling environment.