Strategic Regulatory Labeling Lead – MedTech

PROCEPT BioRobotics Corporation; San Jose, Northern (CA, KY); Hybrid; USD 122,000 - 143,000; Full time

Job summary

PROCEPT BioRobotics Corporation is seeking a Senior Regulatory Affairs Labeling Specialist in San Jose, CA. You will lead regulatory labeling activities for global submissions and author content for user manuals and labeling, ensuring compliance with 21 CFR and EU MDR guidelines.

The role requires 5+ years in medical device regulatory affairs, strong documentation skills, and experience coordinating with engineering, manufacturing, and legal teams.

Qualifications

• Bachelor’s degree in scientific or engineering field preferred.
• 5+ years of experience in medical device regulatory affairs.
• Experience with 510(k) submissions (US).
• Experience with EU MDR/IVDR and 93/42/EEC.
• ISO 13485 experience required.
• Excellent written communication skills.

Responsibilities

• Lead regulatory labeling activities for global submissions and registrations.
• Lead authorship for user manuals, product inserts, and labeling content.
• Provide SME input on labeling requirements and standards.
• Apply style and branding to new and modified labeling.
• Verify labeling complies with applicable requirements.
• Manage external providers for label artwork using design software (e.g., Illustrator) and labeling software (e.g., Bartender).
• Create and revise label items in the document control system.
• Contribute to labeling department process improvements.
• Represent labeling on project teams and assess impact of design changes on labeling content.

Skills

Regulatory affairs

Medical device

Labeling

Documentation

Cross-functional collaboration

Education

Bachelor’s degree in science or engineering

Advanced degree in regulatory affairs (preferred)

Tools

Adobe Illustrator

Bartender

Job description

PROCEPT BioRobotics Corporation is seeking a Senior Regulatory Affairs Labeling Specialist in San Jose, CA. You will lead regulatory labeling activities for global submissions and author content for user manuals and labeling, ensuring compliance with 21 CFR and EU MDR guidelines.

The role requires 5+ years in medical device regulatory affairs, strong documentation skills, and experience coordinating with engineering, manufacturing, and legal teams.