Principal Regulatory Affairs Specialist

Responsibilities

• Regulatory representation and leadership to cross-functional products 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
• Preparing Letters to File documentation to support internal filings for product development projects and product changes not requiring regulatory agency approvals
• 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 RA functional area in the review and approval of Engineering Change Orders (ECO)
• Providing regulatory guidance with regard to the preparation, review and approval of labeling and promotional materials
• Performing regulatory research and staying abreast of changes for US and international regulations and requirements
• Providing regulatory support for quality assurance and regulatory compliance activities as required
• Maintaining well-organized, auditable regulatory files
• Maintaining trained status for, and complying with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance
• Understanding and adhering to the PROCEPT BioRobotics EHS Policy

Qualifications

• Bachelor’s degree in a scientific discipline; advanced degree and RAC (Regulatory Affairs Certificate) preferred
• Minimum of 12 years’ experience in medical device industry with experience in regulatory affairs with direct submissions responsibilities
• Knowledge of relevant Title 21 of the US code of Federal Regulations is required
• Experience with US 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 Quality Management System Standard ISO 13485 is required
• Experience with Risk Management Standard ISO 14971 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
• Able 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