Senior Regulatory Affairs Specialist

Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. Join us as a Senior Regulatory Affairs Specialist and be at the forefront of regulatory science for medical robotics. Provide regulatory guidance to cross-functional partners, develop global regulatory strategies, and prepare and submit regulatory submissions in the US, EU, and outside of the US.

Requirements

• Bachelor’s degree in a scientific or engineering field preferred
• Five (5)-plus years work experience in the medical device field
• Minimum of 5 years’ experience working in regulatory affairs in a medical device company
• Knowledge of Title 21 of the US Code of Federal Regulations (21 CFR 800-1299)
• Experience with US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k)
• Experience with European Medical Device Directive (93/42/EEC with 2007/47/EC) and EU Medical Device Regulation 2017/745
• Experience with Quality Management System Standard ISO 13485
• Excellent written communication skills, especially with technical information
• Proficiency in Microsoft Office Suite preferred
• Precise, thorough, and analytical
• Proactive and adaptable to a fast-paced work environment, including managing multiple projects simultaneously

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