Lead Global Regulatory Labeling Expert (MedTech)

PROCEPT BioRobotics Corporation; United States; On-site; USD 122,000 - 143,000; Full time

Job summary

PROCEPT BioRobotics Corporation is seeking a Senior Regulatory Affairs Specialist (Labeling) to lead global labeling activities, author content for manuals and on-product labeling, and ensure compliance with 21 CFR and EU MDR standards. The role partners with engineering, marketing, manufacturing and legal to drive labeling projects to completion.

The ideal candidate brings 5+ years in medical device regulatory affairs, strong documentation skills, and proficiency with labeling software and

Qualifications

• Bachelor’s degree in a scientific or engineering field.
• 5+ years in medical device regulatory affairs.
• Knowledge of 21 CFR 800-1299 and FD&C Act.
• Experience with EU MDR/IVDR is a plus.
• Experience maintaining labeling content and IFUs.

Responsibilities

• Lead regulatory labeling activities for global submissions.
• Author content for User Manuals, product inserts, and on-product labeling.
• Provide SME input on global labeling requirements and standards.
• Apply branding standards to new or modified labeling.
• Verify labeling compliance with regulatory requirements.
• Manage external design providers for label artwork via Illustrator or Bartender.
• Create and revise label items in document control systems.

Skills

Regulatory labeling

Global regulatory submissions

Labeling content creation

Cross-functional collaboration

Adobe Illustrator

Microsoft Office

Attention to detail

Education

Bachelor’s degree in scientific or engineering field

Advanced regulatory degree or credential preferred

Tools

Adobe Illustrator

Bartender

Labeling software

Job description

PROCEPT BioRobotics Corporation is seeking a Senior Regulatory Affairs Specialist (Labeling) to lead global labeling activities, author content for manuals and on-product labeling, and ensure compliance with 21 CFR and EU MDR standards. The role partners with engineering, marketing, manufacturing and legal to drive labeling projects to completion.

The ideal candidate brings 5+ years in medical device regulatory affairs, strong documentation skills, and proficiency with labeling software and