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 launching diagnostics at the point of care smart/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).