Senior Global Regulatory Labeling Specialist

PROCEPT BioRobotics; San Jose (CA); On-site; USD 122,000 - 143,000; Full time

Job summary

PROCEPT BioRobotics is seeking a Senior Regulatory Affairs Specialist (Labeling) to lead global labeling activities, ensuring clear, compliant user manuals and product labeling for multiple markets. You’ll collaborate with engineering, marketing, manufacturing and legal to support regulatory submissions and labeling workflows.

The role requires deep knowledge of 21 CFR 800–1299, FD&C Act 510(k), EU MDR 2017/745, and hands‑on experience with medical device labeling, IFUs, and artwork management

Qualifications

• Bachelor’s degree in science or engineering required.
• 5+ years of experience in regulatory affairs in a medical device company.
• Knowledge of 21 CFR 800–1299 and FDA regulatory processes.
• Experience with 510(k) submissions.
• Experience with EU MDR/CE marking.
• Ability to work cross-functionally with engineering, marketing, manufacturing and legal.
• Excellent written communication skills and attention to detail.

Responsibilities

• Lead regulatory labeling activities in support of global regulatory submissions for product registrations and variations.
• Lead authorship for content within User Manuals, product inserts, and on‑product labeling.
• Provide SME input on global regulatory labeling requirements and standards; apply branding to labeling.
• Manage external service providers for label artwork using Illustrator and labeling software (e.g., Bartender).
• Create and revise label items in the document control system and release engineering change orders.
• Contribute to Labeling department process improvement initiatives.
• Represent labeling in project teams and interpret impact of design changes on labeling content.

Skills

Regulatory affairs

Medical devices

Cross-functional teamwork

Attention to detail

Technical writing

Education

Bachelor’s degree in science or engineering

Advanced degree in regulatory affairs

Tools

Adobe Illustrator

Bartender

MS Office

Job description

PROCEPT BioRobotics is seeking a Senior Regulatory Affairs Specialist (Labeling) to lead global labeling activities, ensuring clear, compliant user manuals and product labeling for multiple markets. You’ll collaborate with engineering, marketing, manufacturing and legal to support regulatory submissions and labeling workflows.

The role requires deep knowledge of 21 CFR 800–1299, FD&C Act 510(k), EU MDR 2017/745, and hands‑on experience with medical device labeling, IFUs, and artwork management