Job Title: QA/RA LeadEmployment Status: Full-timeOffice Hours: Monday - Friday; hybrid scheduleLocation: Boston, MassachusettsCompensation: $130,000 - $150,000, plus equity options. (Compensation dependent on experience level)As a Ketryx QA/RA Lead, you will lead quality management system implementations and regulatory compliance strategies for cutting-edge medical device clients as we scale our AI-powered compliance platform. This is a rare opportunity to shape the future of regulatory affairs. Youll have the autonomy and expertise to drive repeatable QMS deployment processes while helping shape the future of regulatory affairs through innovative technology and enabling the success of the world's most innovative companies. We offer the opportunity to work with high-growth clients, establishing best-in-class quality systems from the ground up using our revolutionary AI platform.Our ideal candidate will have demonstrated success in quality systems management with 5-8 years of experience in the medical device industry. Someone who is strategic yet hands-on, passionate about regulatory excellence, and eager to leverage cutting-edge AI technology will thrive in this position. In this role, youll have the opportunity to directly impact our mission to improve 100 million patient lives by 2030 by ensuring the highest quality standards for life-saving medical devices.This position will be based in our Boston, Massachusetts office with a hybrid schedule (Monday, Tuesday, Thursday, Friday in office, Wednesday WFH option). Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of employment Visas (including H-1B), F-1 visas, or Optional Practical Training (OPT) status at this time.About You:Youre a proven QMS expert whos successfully navigated complex medical device regulatory landscapes and is ready to scale your impact through innovative technology. Youve built or significantly improved quality systems at medical device companies, consulting firms, or high-growth startups, and youre excited to combine your regulatory expertise with AI-powered tools to create something category-defining.Responsibilities:Lead Quality Management System (QMS) setup and deployment for medical device clientsOwn and manage QMS templates and regulatory compliance frameworksProvide expert consulting on ISO 13485, MDSAP, GxP, and other quality systems standardsScale operations to support high-growth clientsDevelop repeatable QMS deployment processes leveraging AI platform capabilities and automatic complianceShape the future of regulatory affairs through innovative product developmentWork independently on complex quality assurance projects requiring minimal oversightEnsure customer success across the entire customer engagement lifecycleRequired Skills:4-8 years of experience in quality systems management, management representative or senior specialist roleFamiliar with eQMS implementation, validation and implementation.Deep expertise in Quality Management System setup, sub-systems, and implementationStrong knowledge of ISO 13485 and Global QMS requirementsExpertise in AI, Digital, and Cyber ComplianceDeep understanding of medical device cybersecurityExperience as quality management representative in regulated environmentsExperience with regulatory and Notified Body submission requirementsBackground in medical device industry quality systemsAbility to work independently and own complex regulatory projectsProven track record in consulting or client-facing rolesPreferred Skills:Experience at large medical device companies (Stryker, Medtronic, Boston Scientific)Background with consulting firms specializing in QMS setupStartup experience (Series A/B) with QMS implementationSpecializations in cybersecurity, usability, or computer software validationExperience scaling quality operations in high-growth environmentsKnowledge of AI applications in regulatory affairsSubmission experienceKeywords: ISO 13485, MDSAP, Quality Management System (QMS), Management representative, Medical device quality, Stryker, Medtronic, Boston Scientific, QMS setup, Regulatory consulting, Quality systems manager, Computer software validation, Cybersecurity, Usability, Startup experience, Series A/B, Boston/Massachusetts, Consulting firms, Quality assurance, Medical device industry