Regulatory Affairs & Quality

Summary

Join Altoida, a leader in neurological care, as their Head of Regulatory Affairs and Quality. Reporting to the CEO, you will be a key member of the leadership team, responsible for building and evolving the global Quality Management System (QMS). Lead regulatory strategy and submissions, and serve as the primary contact with regulatory bodies like the FDA. This critical role requires shaping a regulatory and quality function that supports innovation while ensuring compliance, embedding regulatory intelligence and quality rigor across the organization. You will collaborate with cross-functional teams and foster a culture of transparency, agility, and excellence. This is a chance to lead, influence strategic outcomes, and contribute to a company defining a new category in precision diagnostics.

Requirements

• 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
• 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

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

Preferred Qualifications

• Familiarity with emerging FDA approaches for adaptive AI/ML-based SaMD, including Predetermined Change Control Plans (PCCPs), is a strong plus
• 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