Terence Musoni

Strategic Policy & Governance for Frontier Technologies

I build the bridges between groundbreaking innovation and responsible, international governance. With over 14 years of experience mastering complex regulatory landscapes in the high-stakes medical technology sector, I specialize in creating the robust frameworks necessary for the safe and ethical deployment of world-changing technology.

Explore My Approach View My Resume

From Regulated Tech to a Regulated Future

Terence Musoni

For more than a decade, I have operated at the intersection of technological advancement and rigorous international regulation. My career has been dedicated to ensuring that complex, life-impacting products not only meet but exceed the highest standards of safety, quality, and efficacy across global markets—from the EU and North America to Asia.

I've learned that true innovation doesn't happen in a vacuum. It requires a robust, proactive, and intelligent governance structure. It involves building systems from the ground up, engaging with regulators as partners, and creating surveillance mechanisms that learn from real-world performance to mitigate risk continuously.

I am now driven to apply this playbook to the defining technology of our time: Artificial Intelligence. My mission is to help Anthropic navigate the emerging global policy landscape, build trust with policymakers and the public, and establish the gold standard for safe and beneficial AI systems.

Core Competencies

Global Regulatory Analysis

Deconstructing and interpreting complex, multi-jurisdictional legal and regulatory frameworks (e.g., EU MDR, MDSAP) to guide strategy and ensure compliance.

Governance & Framework Development

Architecting, implementing, and managing end-to-end quality and safety systems that translate policy into operational reality.

Proactive Risk & Safety Surveillance

Designing and leading post-deployment monitoring programs to identify, investigate, and mitigate potential harms.

International Stakeholder Engagement

Serving as the primary liaison for regulatory bodies (FDA, Health Canada, EU Notified Bodies), auditors, and international partners.

Strategic Pillars

This section reframes my experience into case studies relevant to AI policy.

Architecting International Governance Frameworks

The Challenge:

When new, complex international regulations like the EU's Medical Device Regulation (MDR) were introduced, global organizations needed to fundamentally redesign their governance, documentation, and safety processes to remain compliant and competitive.

My Action:

As a lead consultant at companies like Mevion Medical Systems and Beckman-Coulter, I architected and implemented new Quality Management Systems (QMS) from the ground up. This involved creating new procedures, outlining reporting requirements for every jurisdiction, developing decision-trees for action, and training cross-functional teams on the new operational reality.

The AI Parallel:

This is precisely the work required to operationalize principles from the EU AI Act or the NIST AI Risk Management Framework. My experience is in taking high-level legal requirements and building the tangible, auditable systems that ensure an organization's products and practices are verifiably safe and compliant on a global scale.

Leading Proactive, Post-Deployment Safety Surveillance

The Challenge:

A product's safety profile isn't static at launch. It's critical to continuously monitor its performance in the real world, gather data, and respond to unforeseen events or "malfunctions."

My Action:

At Terumo BCT, Beckman-Coulter, and Philips, I led Post-Market Surveillance (PMS) programs. I created the plans (PMSP) and wrote the reports (PSUR) that analyzed complaint data, scientific literature, and clinical feedback. I evaluated and investigated potential adverse events, determined their root cause (CAPA), and ensured timely reporting to global competent authorities.

The AI Parallel:

This is a direct analogue to the robust model monitoring and incident response required for AI systems. My work involved creating the very feedback loops that are essential for AI safety: monitor for unexpected outputs, investigate why they occurred, mitigate the harm, and report transparently to build trust and inform future development.

Navigating Global Audits & High-Stakes Engagement

The Challenge:

Earning and maintaining the trust of international regulators and partners requires flawless preparation, deep subject matter expertise, and transparent communication.

My Action:

At Allergan and Alcon, I managed the entire site audit program, hosting regulators from the FDA, Health Canada, and EU Notified Bodies (DEKRA, BSI). I was the primary point of contact for quality and compliance issues across EMEA, LACAN, and ASIA. I led for-cause supplier audits internationally, including in Yokohama, Japan (Showa Denko), ensuring partners met our rigorous standards.

The AI Parallel:

An International Policy Advisor must be a credible and trusted voice for the company. I have a proven track record of being that person in high-pressure situations. I am adept at communicating complex technical and process information to regulatory bodies, defending strategic decisions, and holding global partners accountable to shared safety standards.

Resume for Anthropic

TERENCE MUSONI

Fort Worth, TX • 214-309-8175 • tmusoni81@gmail.com • Portfolio Website • LinkedIn Profile

STRATEGIC POLICY & GOVERNANCE PROFESSIONAL

A seasoned governance and regulatory affairs professional with over 14 years of experience building and managing robust compliance and safety frameworks for complex technologies in highly regulated global markets. Proven expertise in translating dense international regulations (EU MDR, ISO 13485) into actionable, auditable corporate policy and procedure. Eager to apply a deep background in risk management, post-deployment surveillance, and regulator engagement to the challenges of AI safety and policy at Anthropic.

CORE COMPETENCIES

  • International Policy Analysis: Expert in navigating multi-jurisdictional regulations (EU, North America, Asia).
  • AI Governance & Risk Management: Deep experience in QMS and Risk Management (ISO 14971), directly translatable to frameworks like the NIST AI RMF.
  • Post-Deployment Safety & Incident Response: Led Post-Market Surveillance (PMS) and Complaint/CAPA systems, analogous to AI model monitoring and red-teaming.
  • Stakeholder & Regulator Engagement: Served as primary liaison for regulators (FDA, Health Canada) and EU Notified Bodies (BSI, TUV).
  • Audit & Accountability: Led and managed international audit programs, including for-cause supplier audits.
  • Cross-Functional Leadership: Coordinated with technical, clinical, and leadership teams to achieve safety and compliance goals.

PROFESSIONAL EXPERIENCE

QMS & Post-Market Surveillance Lead (Contract)

Mevion Medical Systems & Beckman-Coulter | 2020 – Current

  • Architected comprehensive Post-Market Surveillance (PMS) frameworks to align with new, complex international regulations (EU MDR), establishing a model for proactive safety monitoring.
  • Authored strategic governance documents, including PMS Plans and Periodic Safety Update Reports (PSURs), to support technical documentation and certification with EU Notified Bodies (BSI).
  • Translated complex regulatory requirements into clear operational workflows and decision-trees for reporting across multiple jurisdictions.
  • Led training of personnel in new safety and surveillance processes, ensuring enterprise-wide adoption and compliance.

Post-Market Surveillance & Regulatory Consultant (Contract)

Terumo BCT | 2019 – 2020

  • Directed the review of technical documentation and clinical evaluation reports for alignment with EU MDR, focusing on risk, intended use, and robustness of evidence.
  • Analyzed complaint data and scientific literature to identify emerging risk signals, informing risk-benefit analyses and feeding back into product development.
  • Created matrices for tracking and maintaining technical documentation, ensuring continuous compliance for a diverse portfolio of medical devices.

Global RAQA & Audit Program Manager

Alcon/Novartis & Allergan Inc | 2013 – 2018

  • Managed quality and regulatory compliance for affiliates in Europe, Middle East, Africa (EMEA), Latin America/Canada (LACAN), and Asia, maintaining ISO certification across 21 countries.
  • Served as the primary point of contact for global sites on all quality and compliance matters, developing multi-site procedures for CAPA, non-conformance, and product review.
  • Hosted and managed audits from global competent authorities, including FDA (USA), TGA (Australia), MHRA (UK), and EU Notified Bodies (TUV, BSI).
  • Developed and led audit responses, providing strategic guidance to international affiliates and ensuring timely, effective closure of findings.
  • Responded directly to competent authority requests for information related to customer complaints and product recalls.

EDUCATION & CERTIFICATION

Bachelor of Arts, Evolution, Ecology & Organism Biology

The Ohio State University, Columbus, OH

Certified EU MDR 2017/745 Auditor

Oriel Stat-a-Matrix

Let's Connect

I'm passionate about building safe and reliable systems for the future. If you believe my experience in navigating complex regulatory environments could be valuable to Anthropic's mission, I would be delighted to speak with you.

Contact Information

Phone

214-309-8175

Send a Message

Made with DeepSite LogoDeepSite - 🧬 Remix