Senior Regulatory Affairs Lead, Medical Devices & Robotics

PROCEPT BioRobotics Corporation; Headquarters (ID); On-site; USD 148,550 - 174,770; Full time

Job summary

PROCEPT BioRobotics Corporation in Idaho is seeking a Senior Regulatory Affairs Specialist to lead regulatory efforts in medical robotics. You will ensure compliance to regulatory standards while developing strategies for new Class II and III devices.

The ideal candidate will possess a Bachelor's degree in a scientific field and have significant experience in regulatory submissions and compliance issues. The role offers a competitive salary range of $148,550 to $174,770, along with opportunities for growth.

Qualifications

• 6 years’ experience with a B.S. or 4 years’ experience with an M.S. in regulatory submissions for medical devices.
• Experience with regulatory requirements like 21CFR820, ISO13485.
• Ability to manage multiple competing priorities with minimal oversight.

Responsibilities

• Lead regulatory representative on product development teams.
• Develop global regulatory strategies for new and modified products.
• Monitor and interpret regulatory requirements for U.S. and RoW.

Skills

Regulatory submissions for medical devices

Project team collaboration

Analytical skills

Problem-solving skills

Education

Bachelor’s Degree in a scientific discipline

M.S. or Ph.D. in a technical area

Job description

PROCEPT BioRobotics Corporation in Idaho is seeking a Senior Regulatory Affairs Specialist to lead regulatory efforts in medical robotics. You will ensure compliance to regulatory standards while developing strategies for new Class II and III devices.

The ideal candidate will possess a Bachelor's degree in a scientific field and have significant experience in regulatory submissions and compliance issues. The role offers a competitive salary range of $148,550 to $174,770, along with opportunities for growth.