Principal Regulatory Affairs Specialist (San Jose)

Company OverviewEmbark 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 CultureAt PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers.And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.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 finding a work/life balance, we strive to find 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.An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!Company OverviewEmbark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. We 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.The Opportunity That Awaits You: The Principal Regulatory Affairs Specialist provides regulatory leadership for product 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 of the Principal Regulatory Affairs Specialist will be as an individual contributor, reports to the Senior Director of Global Regulatory Affairs.The ideal candidate would have had previous medical device experience and looking for potential for growth.What Your Day-To-Day Will Involve:Regulatory representation and leadership to cross-functional products teams, development of regulatory strategies and support PROCEPT’s products, marketing applications and post-market activitiesProviding training, coaching and mentoring to other regulatory affairs specialistsAssisting in strategic decision making, and representing regulatory at all levels of the businessResponsible 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 guidelinesPrepare Letters to File documentation to support internal filings for product development projects and product changes not requiring regulatory agency approvalsPrepare and maintain Technical Files/Technical Documentation for Europe (CE Mark) for new products, new indications, and significant product changesSupport product development teams on regulatory issues, including review of documentationProvide regulatory assessments for anticipated design, manufacturing, and labeling changesRepresent 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 materialsPerform regulatory research and stay abreast of changes for US and international regulations and requirementsProvide regulatory support for quality assurance and regulatory compliance activities as requiredMaintain well-organized, auditable regulatory filesMaintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory complianceUnderstand and adhere to the PROCEPT BioRobotics EHS PolicyThe Qualifications We Need You to PossessTo 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 RequiredBachelor’s degree in a scientific discipline; advanced degree and RAC (Regulatory Affairs Certificate) preferredMinimum of 12 years’ experience in medical device industry with experience in regulatory affairs with direct submissions responsibilitiesKnowledge of relevant Title 21 of the US code of Federal Regulations is requiredExperience with US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is requiredExperience with European Medical Device Directive (93/42/EEC with 2007/47/EC) is requiredExperience with Quality Management System Standard ISO 13485 is requiredExperience with Risk Management Standard ISO 14971 is requiredKnowledge of EU MDR regulations is requiredKnowledge of International Medical Device requirements (Canada, Australia, New Zealand, China, Japan, etc.) is preferredProficiency in basic computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe AcrobatStrong organization skills, able to manage multiple projects and timelinesCompetence in applying scientific principles and logical thought processes in preparing regulatory documentationExcellent oral and written communication skillsStrong attention to detailAbility to work independently as an individual contributor and in a team environmentKnowledge of software development and software quality as it relates to regulatory submissions a plusSummaryLocation: California - San JoseType: Full time