Senior Regulatory Affairs Leader - Labeling & UDI (Remote)

Jobgether; United States; Remote; USD 120,000 - 150,000; Full time

Benefits offered by this job

Remote working arrangement

Health, dental, and vision insurance

401(k) retirement plan with company-m의

Job summary

Jobgether is seeking a Principal Regulatory Affairs Specialist, Labeling (SWICC) based in the United States. You will lead labeling strategy for medical devices, manage label versions, and ensure compliance across the US, EU, and global markets.

The role involves guiding UDI data management and regulatory submissions while collaborating with R&D, Quality, Marketing, and Manufacturing support teams. The position emphasizes regulatory excellence, timely actions, and a proactive approach to

Qualifications

• Bachelor's degree in a scientific, engineering, or related discipline.
• 7+ years of medical device regulatory affairs experience with labeling experience preferred.
• Experience with FDA labeling requirements and UDI programs is essential.
• Ability to interpret complex regulations and communicate practical implications to stakeholders.

Responsibilities

• Define labeling requirements for products across regions.
• Lead labeling strategy discussions and manage label versions.
• Monitor FDA, EU, and international labeling developments and communicate actions.
• Support UDI data management and submissions, including GUDID/EUDAMED.
• Collaborate with R&D, Quality, Marketing and Manufacturing on regulatory changes.

Skills

Regulatory affairs

Labeling expertise

UDI knowledge

Cross-functional collaboration

Regulatory submissions

MS Office

Education

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

Tools

PLM systems

MS Office (Word, Excel)

Job description

Jobgether is seeking a Principal Regulatory Affairs Specialist, Labeling (SWICC) based in the United States. You will lead labeling strategy for medical devices, manage label versions, and ensure compliance across the US, EU, and global markets.

The role involves guiding UDI data management and regulatory submissions while collaborating with R&D, Quality, Marketing, and Manufacturing support teams. The position emphasizes regulatory excellence, timely actions, and a proactive approach to