Senior Regulatory Labeling Lead, MedTech

PROCEPT BioRobotics K.K.; San Jose (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

PROCEPT BioRobotics, a leader in surgical robotics for BPH, is seeking a Senior Regulatory Affairs Specialist (Labeling) to drive global labeling strategies and compliance. You will own labeling submissions, author manuals and product inserts, and work with cross-functional teams to ensure regulatory alignment across markets.

The role requires 5+ years in regulatory affairs within medical devices, knowledge of 21 CFR 800-1299 and 510(k), and experience with the European Medical Device Directive.

Qualifications

• Bachelor's degree in science or engineering field.
• 5+ years in medical device field.
• 5+ years regulatory affairs in medical devices.
• Knowledge of 21 CFR 800-1299.
• Experience with FD&C Act 510(k).
• Experience with European Medical Device Directive.

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 style guidelines to labeling.
• Manage external service providers in designing label artwork using design software (e.g., Adobe Illustrator) and labeling software (e.g., Bartender).
• Create and revise label items within the document control system, drafting and releasing engineering change orders.
• Contribute to Labeling department process improvement initiatives.
• Represent Regulatory Affairs labeling on project teams, interpreting labeling impacts of design changes and implementing necessary modifications.

Skills

Regulatory affairs

Labeling

Cross-functional teamwork

Education

BSc in science/engineering

Job description

PROCEPT BioRobotics, a leader in surgical robotics for BPH, is seeking a Senior Regulatory Affairs Specialist (Labeling) to drive global labeling strategies and compliance. You will own labeling submissions, author manuals and product inserts, and work with cross-functional teams to ensure regulatory alignment across markets.

The role requires 5+ years in regulatory affairs within medical devices, knowledge of 21 CFR 800-1299 and 510(k), and experience with the European Medical Device Directive.