Remote Global Regulatory Labeling & UDI Lead

Jobgether; United States; À distance; USD 120 000 - 150 000; Plein temps

Avantages offerts par ce poste

Remote working arrangement

Health, dental, and vision insurance

401(k) retirement plan with company匹配

Paid time off

Tuition reimbursement

Résumé du poste

Jobgether seeks a principal Regulatory Expert for labeling and UDI in the United States and international markets. You will set regulatory labeling requirements, guide product teams, and ensure compliant labeling across multiple jurisdictions.

You will monitor FDA and EU developments, define labeling requirements per product family, and coordinate with global regulatory units to implement country-specific rules. Remote-ready role with global travel.

Qualifications

• Bachelor's degree in a scientific, engineering, or related discipline.
• 7+ years in medical device regulatory affairs, incl. 3+ years labeling.
• Experience with FDA labeling, UDI requirements, and ISO 13485.

Responsabilités

• Lead regulatory labeling strategy for medical devices and IFUs.
• Manage large portfolio of labels and versions, track changes.
• Monitor FDA, EU, and international labeling developments and communicate actions.

Connaissances

Regulatory labeling

FDA CFR knowledge

EU MDR understanding

GUDID/EUDAMED data mgmt

Change control & PLM

Cross-functional collaboration

Formation

Bachelor's degree in science/engineering

Outils

PLM systems

MS Word

MS Excel

Description du poste

Jobgether seeks a principal Regulatory Expert for labeling and UDI in the United States and international markets. You will set regulatory labeling requirements, guide product teams, and ensure compliant labeling across multiple jurisdictions.

You will monitor FDA and EU developments, define labeling requirements per product family, and coordinate with global regulatory units to implement country-specific rules. Remote-ready role with global travel.