Senior MedTech Labeling & Regulatory 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) in San Jose, CA to lead labeling activities for global regulatory submissions. You will author content for manuals, labels, and inserts, and ensure compliance across US and international markets.

The role requires 5+ years in medical device regulatory affairs, knowledge of 21 CFR 801-1299 and EU MDR 2017/745, ISO 13485, and strong cross-functional collaboration with engineering, marketing, and legal teams.

Qualifications

• Bachelor's degree in science or engineering required; advanced degree preferred.
• 5+ years in regulatory affairs for medical devices.
• Knowledge of 21 CFR 801-1299; experience with 510(k).
• Experience with EU MDR 2017/745.
• ISO 13485 knowledge.
• Strong cross-functional teamwork and communication.

Responsibilities

• Lead regulatory labeling activities for global submissions and variations.
• Authorship for User Manuals, product inserts, and labeling content.
• Advise on global labeling requirements and ensure compliance with standards.
• Manage external providers for label artwork using Illustrator and Bartender.
• Create and revise label items in the document control system; issue changes.
• Contribute to labeling process improvements and project collaboration.

Skills

Regulatory labeling

Global submissions

Content authoring

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in science or engineering

Advanced degree (preferred)

Tools

Adobe Illustrator

Bartender

MS Office

Job description

PROCEPT BioRobotics is seeking a Senior Regulatory Affairs Specialist (Labeling) in San Jose, CA to lead labeling activities for global regulatory submissions. You will author content for manuals, labels, and inserts, and ensure compliance across US and international markets.

The role requires 5+ years in medical device regulatory affairs, knowledge of 21 CFR 801-1299 and EU MDR 2017/745, ISO 13485, and strong cross-functional collaboration with engineering, marketing, and legal teams.