JOB DESCRIPTION:

Seeking a Regulatory Affairs Associate to support international addendum labelling (IFUs, import labels, and country-specific labeling) for medical devices. This role involves collaboration with global RA teams and ownership of labeling compliance processes.

Responsibilities:

• Develop and design compliant labeling, including IFUs and international labels.
• Coordinate cross-functional teams and manage multiple labeling projects.
• Implement changes per international regulatory guidelines.
• Fill out forms, revue redlines and submit packages to the labeling team.
• Track labeling change requests and maintain documentation for audits.
• Monitor global regulatory trends and update internal procedures.
• Support quality system improvements and KPI reporting.

Requirements:

• Bachelor’s degree in Regulatory Affairs, Biomedical Engineering, or related field.
• 4+ years in regulatory/quality operations within a regulated industry.
• Experience with labeling design, document control, and regulatory submissions.
• Strong knowledge of FDA and international device labeling regulations.
• Proficiency in SAP, Adobe Acrobat, and MS Office.
• Experience with Class III implantable medical devices.
• Hands-on with PMA supplements, change assessments, and audit preparation.
• Strong project coordination and stakeholder communication skills.

• Develop and design compliant labeling, including IFUs and international labels.
• Coordinate cross-functional teams and manage multiple labeling projects.
• Implement changes per international regulatory guidelines.
• Fill out forms, revue redlines and submit packages to the labeling team.
• Track labeling change requests and maintain documentation for audits.
• Monitor global regulatory trends and update internal procedures.
• Support quality system improvements and KPI reporting