Remote Global Regulatory Labeling Lead – Med Devices

Getinge; Lansing (MI); Sur place; USD 120 000 - 150 000; Plein temps

Avantages offerts par ce poste

Health insurance

401k with company match

Paid time off

Wellness program

Life insurance

Short/Long disability

FSA

Commuter benefits

Parental leave

Tuition reimbursement

Résumé du poste

Getinge seeks a Principal Regulatory Affairs Labeling Specialist to own labeling strategy for SWICC consumables and lead global UDI compliance. You will work with R&D, Quality, Marketing and Regulatory teams across US, EU and other regions to ensure labels meet regulatory expectations and lifecycle requirements.

The role requires expert knowledge of FDA/EU labeling, PLM/workflow processes, and translation considerations.

Qualifications

• Expert knowledge of labeling, PLM and change control.
• Ability to interpret regulations and explain labeling requirements.
• Experience with global labeling across US, EU and rest of world.

Responsabilités

• Leads regulatory labeling strategy discussions for SWICC consumables.
• Manages high volume of labels and label versions across portfolio.
• Monitors FDA, EU and other labeling and UDI requirements.
• Guides cross-functional teams on labeling requirements.
• Maintains regional labeling language and translation expectations.
• Evaluates regulatory changes and documents impact and actions.
• Defines labeling requirements per product family and market.
• Reviews regulatory documentation and supports e-labeling and artwork.

Connaissances

Regulatory labeling

UDI requirements

Global labeling

Regulatory affairs

Change control

PLM experience

Interpersonal skills

Regulatory strategy

Formation

Bachelor's degree in science/engineering

Outils

MS Office

PLM systems

Description du poste

Getinge seeks a Principal Regulatory Affairs Labeling Specialist to own labeling strategy for SWICC consumables and lead global UDI compliance. You will work with R&D, Quality, Marketing and Regulatory teams across US, EU and other regions to ensure labels meet regulatory expectations and lifecycle requirements.

The role requires expert knowledge of FDA/EU labeling, PLM/workflow processes, and translation considerations.