Principal Regulatory Affairs Specialist

Company Overview 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. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities. Understanding PROCEPT’s Culture: We believe every person matters. Every employee, every patient, every caregiver. We are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in humility and high engagement, working together seamlessly for a common goal. Curiosity, ingenuity and conviction in the power of technology will transform the lives of patients and providers. Our program includes a live induction program and an industry‑leading management program designed to build the best managers. We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just work/life balance, striving for a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances. The Opportunity That Awaits You The Principal Regulatory Affairs Specialist provides regulatory leadership for products manufactured by PROCEPT BioRobotics (“company”) from development through marketing approval and commercialization. Responsibilities include coordination and preparation of regulatory submissions and for the development/revision of procedures and practices to ensure compliance with FDA and international regulations, guidelines, and standards, and providing regulatory guidance to project teams. The initial role will be as an individual contributor, reporting to the Senior Director of Global Regulatory Affairs. The ideal candidate would have previous medical device experience and a potential for growth. What Your Day-To-Day Will Involve Regulatory representation and leadership to cross‑functional product teams, development of regulatory strategies and support PROCEPT’s products, marketing applications and post‑market activities Providing training, coaching and mentoring to other regulatory affairs specialists Assisting in strategic decision making, and representing regulatory at all levels of the business Responsible for project timelines and management of regulatory submissions including preparing IDE, 510K and international submissions for new products, new indications, and significant product changes to ensure compliance with the FDA and international regulations and guidelines Prepare Letters to File documentation to support internal filings for product development projects and product changes not requiring regulatory agency approvals Prepare and maintain Technical Files/Technical Documentation for Europe (CE Mark) for new products, new indications, and significant product changes Support product development teams on regulatory issues, including review of documentation Provide regulatory assessments for anticipated design, manufacturing, and labeling changes Represent RA functional area in the review and approval of Engineering Change Orders (ECO) Provide regulatory guidance with regard to the preparation, review and approval of labeling and promotional materials Perform regulatory research and stay abreast of changes for US and international regulations and requirements Provide regulatory support for quality assurance and regulatory compliance activities as required Maintain well‑organized, auditable regulatory files Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance Understand and adhere to the PROCEPT BioRobotics EHS Policy The Qualifications We Need You To Possess To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Qualifications / Skills Required Bachelor’s degree in a scientific discipline; advanced degree and RAC (Regulatory Affairs Certificate) preferred Minimum of 12 years’ experience in the medical device industry with direct regulatory affairs submission responsibilities Knowledge of Title 21 of the U.S. Code of Federal Regulations is required Experience with U.S. Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is required Experience with European Medical Device Directive (93/42/EEC with 2007/47/EC) is required Experience with ISO 13485:2016 Quality Management System Standard is required Experience with ISO 14971 risk management standard is required Knowledge of EU MDR regulations is required Knowledge of International Medical Device requirements (Canada, Australia, New Zealand, China, Japan, etc.) is preferred Proficiency in basic computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat Strong organization skills, able to manage multiple projects and timelines Competence in applying scientific principles and logical thought processes 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 is a plus Pay Range For This Role $220,670 to $259,610 #J-18808-Ljbffr