Senior Regulatory Affairs Specialist (Labeling)
PROCEPT BioRoboticsSan Jose, California, United States
Posted March 19, 2026
120000 - 144000 USD
Full Time
About the Company
PROCEPT BioRobotics is a medical device company that puts the patient first in everything they do, committed to revolutionizing treatment for benign prostatic hyperplasia (BPH) through innovation in surgical robotics.
Job Description
Join PROCEPT BioRobotics as a Senior Regulatory Affairs Specialist (Labeling) and contribute to the growth of the department while advancing your understanding of regulatory compliance, technical content creation, and product development. Lead regulatory labeling activities in support of global regulatory submissions and provide SME input on global regulatory labeling requirements and standards.
Requirements
- Bachelor’s degree, in scientific or engineering field preferred
- Five (5)-plus years work experience in medical device field
- Minimum of 5 years’ experience working in regulatory affairs in a medical device company
- Knowledge of Title 21 of the US code of Federal Regulations (21 CFR 800-1299)
- Experience with US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k)
- Experience with European Medical Device Directive (93/42/EEC with 2007/47/EC) and EU Medical Device Regulation 2017/745
- Experience with Quality Management System Standard ISO 13485
- Experience working cross-functionally with engineering, marketing, manufacturing, and legal teams
Benefits
- Full medical coverage
- Wellness programs
- On-site gym
- 401(k) plan with employer match
- Short-term and long-term disability coverage
- Basic life insurance
- Wellbeing benefits
- Flexible or paid time off
- Paid parental leave
- Paid holidays
