xBxBio Opens EU, Asia and Latin America Regulatory Leadership Searches

IRVINE, Calif. - EntSun -- xBxBio is seeking three senior vice presidents to strengthen regulatory strategy and governance for its developing cardiovascular intelligence platform, with one position each for the European Union, Asia, and Latin America.

The searches support preparation for future international development by bringing regional expertise into scientific, engineering, clinical, and quality planning.

xBxBio is developing Connected Cardiovascular Intelligence™ to help clinicians assess patient-specific cardiovascular information across sources and over time when developing recommendations for individual patients. Regional leaders will help connect development priorities with applicable requirements, evidence needs, and quality processes.

Senior Vice President, Regulatory Affairs & Governance — European Union

This leader will guide EU regulatory strategy for applicable medical-device software and clinical AI functions. Responsibilities include intended-use and classification assessments, conformity assessment planning, clinical evidence strategy, and coordination with quality, engineering, clinical, privacy, and legal specialists.

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Senior Vice President, Regulatory Affairs & Governance — Asia

This leader will develop country-specific strategies for selected Asian markets. Responsibilities include helping to prioritize jurisdictions, assessing regulatory pathways and evidence requirements, identifying local expertise, and coordinating submission planning.

Senior Vice President, Regulatory Affairs & Governance — Latin America

This leader will develop country-specific strategies for selected Latin American markets. Responsibilities include assessing product classification and registration pathways, identifying local representation and documentation requirements, and coordinating evidence and submission planning with regional specialists.

Both Asia and Latin America require strategies tailored to individual countries. All three leaders will support the regional application of xBxBio's Regulatory-by-Design Framework, emphasizing traceable decisions, evidence planning, risk management, and accountable human oversight.

Candidate qualifications

Candidates should demonstrate substantial regional experience with medical devices, medical software, or clinical AI; multidisciplinary leadership; and a verifiable record of translating regulatory requirements into practical development and evidence plans.

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How to apply

Email HR@xbxbio.com with a current executive CV or résumé, a concise statement of qualifications, and five verifiable examples of relevant results you personally led or materially contributed to. Describe your contribution, outcomes, and experience with specific jurisdictions and regulatory pathways.

Use "SVP Regulatory Affairs & Governance — EU," "SVP Regulatory Affairs & Governance — Asia," or "SVP Regulatory Affairs & Governance — Latin America" in the subject line. Exclude confidential, proprietary, patient-identifiable, or otherwise restricted information.

About xBxBio

xBxBio is developing a cardiovascular intelligence platform focused on longitudinal clinical context, multimodal information, interoperability, data integrity, and clinician-guided recommendations.

The company remains in pre-commercial research and engineering development. Future clinical deployment and commercialization depend on appropriate verification, validation, clinical evidence, and applicable regulatory requirements and authorizations.

Website: https://www.xbxbio.com
Executive applications: HR@xbxbio.com