Principal Regulatory Affairs Specialist

Overview The Principal Regulatory Affairs Specialist provides regulatory leadership for products manufactured by PROCEPT BioRobotics from development through marketing approval and commercialization. The role is an individual contributor reporting to the Senior Director of Global Regulatory Affairs. Responsibilities Regulatory representation and leadership to cross‑functional product teams, including development of regulatory strategies and support for marketing applications and post‑market activities. Providing training, coaching, and mentoring to other regulatory affairs specialists. Assisting in strategic decision‑making and representing regulatory affairs at all business levels. Managing project timelines and regulatory submissions, including IDE,510(k), and international submissions for new products, new indications, and significant product changes. Preparing Letters to File documentation for internal filings and support of product development projects. Preparing and maintaining Technical Files / Technical Documentation for Europe (CE Mark) for new products, new indications, and significant product changes. Supporting product development teams on regulatory issues, including review of documentation. Providing regulatory assessments for anticipated design, manufacturing, and labeling changes. Representing the RA functional area in the review and approval of Engineering Change Orders (ECO). Providing regulatory guidance on preparation, review, and approval of labeling and promotional materials. Performing regulatory research and staying abreast of changes in US and international regulations and requirements. Providing regulatory support for quality assurance and regulatory compliance activities. Maintaining well‑organized, auditable regulatory files and ensuring compliance with the PROCEPT BioRobotics Quality Management System. Upholding the PROCEPT BioRobotics EHS Policy. Qualifications Bachelor’s degree in a scientific discipline; advanced degree and Regulatory Affairs Certificate (RAC) preferred. Minimum 12 years of experience in the medical device industry with direct regulatory affairs submission responsibilities. Knowledge of Title21 U.S. Code of Federal Regulations. Experience with FDA510(k) submissions. Experience with the European Medical Device Directive (93/42/EEC with 2007/47/EC). Experience with ISO13485 Quality Management System. Experience with ISO14971 Risk Management. Knowledge of EU MDR regulations. Knowledge of international medical device requirements in Canada, Australia, New Zealand, China, Japan, etc. (preferred). Proficiency with Microsoft Office Suite (Word, PowerPoint, Excel) and Adobe Acrobat. Strong organizational skills and ability to manage multiple projects and timelines. Competence in applying scientific principles and logical thinking in preparing regulatory documentation. Excellent oral and written communication skills. Strong attention to detail. Ability to work independently as an individual contributor and in a team environment. Knowledge of software development and software quality as it relates to regulatory submissions (a plus). Salary Pay Range: $220,670 to $259,610. #J-18808-Ljbffr