Regulatory Affairs Lead: Medical Robotics Submissions

PROCEPT BioRobotics; California (MO); On-site; USD 80,000 - 120,000; Full time

Job summary

PROCEPT BioRobotics in California is seeking a Staff Regulatory Affairs Specialist to lead regulatory initiatives for medical robotics, focusing on compliance and innovation in treating benign prostatic hyperplasia (BPH).

Ideal candidates should have a Bachelor’s in a scientific discipline, extensive experience in regulatory submissions for medical devices, and strong problem-solving skills. Join us to make a significant impact in urological surgery.

Qualifications

• 8 years of experience with a B.S. or 6 years of experience with a M.S. in regulatory submissions for medical devices.
• Experience with 21 CFR 820, ISO 13485, Medical Devices Directive, or IVD Directive.
• Strong attention to detail and ability to manage multiple priorities.

Responsibilities

• Act as a lead regulatory representative on core product development teams.
• Develop global regulatory strategies for new and modified products.
• Provide regulatory guidance to cross-functional partners.

Skills

Regulatory submissions

Project management

Analytical skills

Problem-solving

Strong communication

Education

Bachelor’s Degree in a scientific discipline

Master’s or Ph.D. in a technical area

Job description

PROCEPT BioRobotics in California is seeking a Staff Regulatory Affairs Specialist to lead regulatory initiatives for medical robotics, focusing on compliance and innovation in treating benign prostatic hyperplasia (BPH).

Ideal candidates should have a Bachelor’s in a scientific discipline, extensive experience in regulatory submissions for medical devices, and strong problem-solving skills. Join us to make a significant impact in urological surgery.