Senior Regulatory Affairs Specialist
PROCEPT BioRoboticsSan Jose, California, United States
Posted March 19, 2026
120000 - 144000 USD
Full Time
About the Company
PROCEPT BioRobotics is a company that puts the patient first and is committed to revolutionizing treatment for benign prostatic hyperplasia through innovation in surgical robotics.
Job Description
Join PROCEPT BioRobotics as a Senior Regulatory Affairs Specialist and be at the forefront of regulatory science for medical robotics. Provide regulatory guidance to cross-functional partners, develop global regulatory strategies, and prepare regulatory submissions.
Requirements
- Bachelor's Degree in Scientific discipline
- 6 years experience with a B.S. or 4 years experience with a M.S. in regulatory submissions for medical devices
- Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC)
- Ability to work effectively on project teams
- Must be able to manage multiple and competing priorities and manage programs with minimal oversight
Benefits
- Comprehensive benefits package
- Full medical coverage
- Wellness programs
- 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
