Head of Regulatory Affairs & Quality

Altoida; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Altoida is seeking a Head of Regulatory Affairs and Quality to lead their global Quality Management System and regulatory strategy. This role involves collaboration with cross-functional teams and ensuring compliance with FDA and international regulations. The ideal candidate will have extensive experience in quality management for clinical diagnostics and a proven track record in regulatory submissions.

Qualifications

• 7–10+ years of experience in quality management systems for clinical and diagnostics companies.
• Deep regulatory expertise with FDA De Novo and 510(k) submissions.

Responsibilities

• Lead regulatory strategy and quality oversight for AI/ML lifecycle management.
• Ensure compliance with ISO 13485 and FDA regulations.
• Oversee post-market surveillance and complaint handling processes.

Skills

Leadership

Regulatory Expertise

Quality Management

Creative Thinking

Job description

Altoida is defining a new category in neurological care with a first-of-its-kind, multi-modal platform built to unlock access to clinical-grade cognitive and functional diagnostics at the front lines of healthcare. Combining augmented reality (AR), sensor fusion, and explainable AI, Altoida’s Digital NeuroMarker Platform delivers a 10-minute, self-administered assessment—designed for both in-clinic and remote use—that captures hundreds of digital biomarkers across motor, speech, AR and cognitive domains. The platform is intended to detect signs of Mild Cognitive Impairment (MCI) and Alzheimer’s disease earlier and more objectively than traditional clinical methods.

Built on more than 20 years of scientific research and shaped by research on nearly 20,000 participants and tens of thousands of assessments, Altoida’s platform has been featured in Nature Digital Medicine and is already in use by global pharmaceutical leaders to support clinical trial enrichment, optimal screening, treatment monitoring, and disease progression research.

By delivering scalable, real-time diagnostics that fit within primary care workflows, Altoida aims to dramatically expand access to critical cognitive evaluations—empowering providers to identify at-risk individuals earlier and intervene when it matters most.

With platform extensibility across a range of neurological and neuropsychiatric conditions—from Parkinson’s and traumatic brain injury to depression and beyond—Altoida is building the diagnostic infrastructure for precision brain health at global scale. For more information, visit www.altoida.com. Follow us on Twitter @altoida.

About the Role:

The Head of Regulatory Affairs and Quality will be a key member of Altoida’s leadership team, reporting directly to the CEO. This individual will own and evolve our global Quality Management System, lead regulatory strategy and submissions, and serve as the primary point of contact with regulatory bodies including the FDA, notified bodies, and other international authorities as applicable.

As Altoida pioneers a new class of AI/ML-enabled digital biomarkers,this role is critical in shaping a regulatory and quality function that supports innovation while ensuring compliance. You will be responsible for embedding regulatory intelligence and quality rigor across the organization—from early product design to post-market surveillance.

Success in this role requires more than technical fluency. You’ll be a trusted coach and thought partner, known for driving clarity, setting a high bar, and simplifying complexity. You will collaborate closely with cross-functional teams—including product,data science, clinical, and commercial—while fostering a culture of transparency, agility, and excellence.

This is an opportunity to lead by example, influence strategic outcomes, and help build a category-defining company that brings life-changing precision diagnostics to patients worldwide.

Responsibilities

• Lead regulatory strategy and quality oversight for AI/ML lifecycle management, including change control processes for learning algorithms.
• Lead development and implementation of regulatory strategies for new and modified devices by preparing submissions and interfacing with the FDA, notified bodies, and other international authorities.
• Lead the preparation and planning for regulatory submissions (510(k), CE Marking, Design Dossiers, international licenses, as applicable), and manage responses to regulatory queries and inspection non- conformance.
• Apply a least burdensome regulatory approach while ensuring appropriate design, manufacturing, distribution, and commercial controls to support innovation and business growth.
• Interpret and communicate regulatory expectations to internal and external stakeholders, including partners, supply chain, CROs, consultants, and contractors, to ensure program objectives align with applicable regulations.
• Promote a company-wide understanding of key elements related to quality and regulatory requirements.
• Serve as the Management Representative in compliance with ISO 13485 and 21 CFR Part 820.20.
• Lead the continued development, simplification, and improvement of Altoida’s Quality Management System.
• Ensure all design and development activities are carried out in accordance with ISO 13485 and 21 CFR Part 820.30.
• Ensure QMS and product development processes integrate cybersecurity, data integrity, and real-world data handling requirements in compliance with FDA and international standards.
• Lead a value-added auditing program focused on risk-based regulatory compliance.
• Oversee post-market surveillance, complaint handling, and CAPA processes to ensure ongoing compliance and continuous improvement.
• Drive improvements aligned to quality KPIs and other performance metrics.
• Build partnerships with key stakeholders across functions to support business objectives through the sharing of quality and regulatory expertise.
• Oversees post-market surveillance, complaint handling, and CAPA processes to ensure ongoing compliance and continuous improvement.

Professional Qualifications

• 7–10+ years of experience building and implementing effective quality management systems for clinical and diagnostics companies, with a focus on Software as a Medical Device.
• Proven track record of leadership in quality organizations, including the development of long-term strategic initiatives and scaling for growth.
• Deep regulatory expertise with FDA De Novo and 510(k) submissions, CE marking, and interactions with notified bodies. Demonstrated success leading audits and achieving certifications and re-certifications.
• Skilled in navigating regulatory frameworks specific to SaMD, including IMDRF guidance and FDA’s Clinical Evaluation guidance.
• Familiarity with emerging FDA approaches for adaptive AI/ML-based SaMD, including Predetermined Change Control Plans (PCCPs), is a strong plus.
• Knowledge of the FDA’s proposed Quality Management System Regulation (QMSR) aligning with ISO 13485.
• Strong understanding of risk-based decision-making and the ability to develop and present effective, pragmatic regulatory and quality strategies.
• Willingness to travel regularly, as needed.

Individual Traits

• Creative thinker with a track record of developing novel solutions to complex problems and driving them to completion.
• High level of personal and professional integrity; self-directed, accountable, and able to thrive with minimal oversight.
• Excellent interpersonal and leadership skills; adaptable, collaborative, and effective in fast-paced environments.
• Thoughtfully and constructively challenges.
• Open to and encourages inquiry and debate; intellectually curious.
• Gritty; resilient and determined.
• Willing and able to get in the details to design and maintain a best-in-class QMS.
• Focuses on execution and outcomes, not on effort.
• Team player.