Xenter

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).