Principal Regulatory Affairs Specialist

Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics.

Requirements

• Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
• 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

• Full medical coverage
• Wellness programs
• On-site gym
• 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