PROCEPT BioRobotics - Principal Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist

San Jose, CA

RAQA /

Full-Time /

Hybrid

Home Address (Please indicate full home address including house number, city, state and zip. This field helps us in the future stages as we work on offers etc)

Were you referred or do you have a reference for this position? A referral means a current Procept employee has personally reached out and recommended you for this position. A reference is someone that works at PROCEPT and who can speak to your experience/qualifications, such as a former colleague.
- Referral
- Reference
If yes, please provide their full name:

Do you have 5+ years of direct experience authoring complex regulatory submissions for Class II or Class III medical devices? Please briefly provide an example of a complex submission you authored/led.
Have you served as the lead regulatory affairs SME on new product development core teams? Please provide a brief example of one of these development projects.
Do you have hands-on expertise in developing regulatory strategies for hardware and software medical device technologies, including SaMD, AI, Machine Learning, Cybersecurity, etc.? If so, please briefly provide a couple of examples to illustrate this experience.
Would you be willing to relocate?