Director, Regulatory Affairs & Quality Systems

Director, Regulatory Affairs & Quality Systems About Xenter Xenter is a technology in medicine company that is bringing medical devices to the digital age. Xenter is revolutionizing medicine by developing and launch ing diagnostics at the point of care sm art/wireless guidewires and catheters that transmit data through a proprietary wireless network to our proprietary cloud that collects and houses real-time Physical Intelligence medical data. Position Summary The Vice President of Regulatory Affairs & Quality Systems will serve as Xenter's senior leader accountable for the full RA/QA function. Reporting to the CEO, this executive will set global regulatory strategy, own the quality management infrastructure, and build the organizational capability needed to scale from a development-stage company through commercialization and public company readiness. The VP will be a key voice at the leadership table, partnering with R&D, Digital, Clinical, Commercial, and Finance leaders to enable compliant, timely product launches and investor-ready governance. Key Responsibilities Regulatory Strategy & Leadership Set and own global regulatory strategy across the full product portfolio, including digital cloud/AI tools, diagnostic, Class II and emerging Class III pathways. Lead regulatory submissions (510(k), IDE, PMA, De Novo) and all agency interactions, including FDA meetings and correspondence. Provide regulatory counsel to the executive team on product strategy, clinical design, and commercialization planning. Anticipate the regulatory environment—tracking FDA guidance, policy changes, and international developments—and position Xenter proactively. Represent Xenter in interactions with regulatory bodies, notified bodies, and external partners. Quality Systems Oversight Own the design, implementation, and continuous improvement of a scalable QMS compliant with 21 CFR Part 820 and ISO 13485. Establish and govern CAPA, complaint handling, MDR, post-market surveillance, supplier quality, and audit programs. Ensure design control integrity (DHF, DMR, DHR) and risk management alignment with ISO 14971 across the product lifecycle. Drive quality culture and accountability across the organization. Inspection & Audit Readiness Serve as the executive leader responsible for FDA inspection readiness and outcomes. Lead preparation of the organization, including executive leadership and the Board, for agency interactions. Oversee ISO 13485 certification, surveillance audits, and remediation programs. Pre-IPO & Investor Readiness Build RA/QA infrastructure and documentation that withstands public company scrutiny and investor due diligence. Develop KPIs, risk frameworks, and board-level reporting for regulatory and quality performance. Serve as subject matter authority in financing, M&A, and partnership transactions. Organizational Leadership Build, mentor, and scale the RA/QA team, including direct hires, contractors, and consulting partners. Establish the operating model, budget, and talent strategy for the function. Model a culture of quality, compliance, and operational excellence across Xenter. Qualifications Required Bachelor's degree in life sciences, engineering, information security or related field; advanced degree strongly preferred. 15+ years of progressive regulatory affairs and quality systems experience in medical devices and software. Demonstrated track record leading FDA submissions and agency interactions at a senior level. Extensive knowledge of 21 CFR Part 820, ISO 13485, and applicable global regulatory frameworks. Experience with Class II and/or Class III device submissions, including complex or novel technologies. Proven ability to lead and scale RA/QA functions in a growth-stage environment. Executive presence and experience presenting to boards, investors, and senior leadership. Preferred Experience guiding a company through an IPO or significant capital raise. Global regulatory experience (EU MDR, Canada, Japan, or APAC). Experience with software-enabled, connected, or digital health medical devices. RAC certification (Regulatory Affairs Certified) or equivalent credential. ASQ Certified Quality Auditor (CQA) or Quality Manager (CQM). Experience implementing enterprise quality management systems (eQMS). #J-18808-Ljbffr