Regulatory Strategy Lead - Medical Devices

PROCEPT BioRobotics; San Jose (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

PROCEPT BioRobotics is seeking a Principal Regulatory Affairs Specialist to provide regulatory leadership from development through marketing approval. You will coordinate regulatory submissions, ensure compliance with FDA and international regulations, and guide project teams on regulatory strategies.

The ideal candidate will have medical device regulatory experience, strong documentation skills, and the ability to work independently while collaborating across functions.

Qualifications

• Bachelor’s degree in a scientific discipline; RAC preferred.
• Minimum 12 years in medical device regulatory affairs with direct submissions responsibilities.
• Strong knowledge of US 21 CFR and FD&C Act requirements.
• Experience with EU MDR and international regulatory requirements.

Responsibilities

• Lead regulatory strategies for cross‑functional product teams and submissions.
• Mentor regulatory specialists and provide training.
• Coordinate IDE, 510(k), and international submissions for new products/indications.
• Prepare and maintain EU Technical Files/Documentation for CE marking.

Skills

Regulatory leadership

Cross-functional collaboration

Project management

FDA 510(k) knowledge

EU MDR knowledge

ISO 13485 knowledge

Regulatory documentation

Communication skills

Independent contributor

Software development awareness

Education

Bachelor’s degree in a scientific discipline

RAC certification (preferred)

Tools

Microsoft Office

Adobe Acrobat

Job description

PROCEPT BioRobotics is seeking a Principal Regulatory Affairs Specialist to provide regulatory leadership from development through marketing approval. You will coordinate regulatory submissions, ensure compliance with FDA and international regulations, and guide project teams on regulatory strategies.

The ideal candidate will have medical device regulatory experience, strong documentation skills, and the ability to work independently while collaborating across functions.