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Aetonix · 1 day ago

Regulatory & Quality Manager

United States

Full-time

Remote

Senior Level, Lead/Staff

8+ years exp

Aetonix is a rising leader in healthcare technology, focused on connecting clinicians and patients through innovative solutions. The Regulatory & Quality Manager will own the product vision and strategy for Aetonix's chronic care management platform, ensuring compliance and quality while driving product innovation.

Elder CareHealth CareHome Health CareMobile AppsSoftware

Growth Opportunities

Responsibilities

Design and execute a phased regulatory and quality roadmap aligned to Aetonix's targeted early, mid, and future-stage product maturity

Define and champion threshold excellence — articulating clear criteria for what is required now versus what is required for scale as product capabilities mature

Ensure regulatory and quality processes enable, rather than hinder, product innovation, iteration speed, and commercial readiness

Establish decision frameworks that allow teams to confidently answer safety and compliancy concerns prior to feature releases and deployment (including AI)

Provide regulatory leadership for Software as a Medical Device (SaMD) supporting remote chronic care delivery

Interpret and apply regulatory requirements pragmatically, including FDA (21 CFR Part 820, SaMD guidance), Health Canada (Class II), ISO 13485, IEC 62304, ISO 14971, and EU MDR

Advise Product and Engineering on SaMD classification, intended use, and regulatory pathways as capabilities evolve from rules-based logic to AI-powered adaptive systems

Own regulatory strategy for determining when product changes constitute significant modifications requiring regulatory notification or submission

Ensure regulatory practices support US reimbursement requirements foundational to the commercial model

Establish regulatory frameworks for EHR and BYOD device integrations, including FHIR/HL7 compliance and API security and validation where required

Oversee product risk management per ISO 14971, addressing multi-user risk scenarios, software and algorithmic risks, clinical workflow integration risks, and remote care delivery risks

Establish and maintain a velocity-enabling QMS appropriate for an early-stage digital health organization building SaMD

Own core quality processes: document control, design controls and DHF, risk management (ISO 14971), change management, CAPA, internal audits, supplier management

Ensure the QMS supports software development practices including agile workflows, CI/CD where appropriate, version control, and DevOps with embedded quality gates

Build QMS maturity in phases: establish essentials in Phase 1, scale for AI/ML and devices in Phase 2

Serve as the primary owner and decision authority for AI/ML governance across all AI-enabled SaMD capabilities

Define, implement, and maintain the company’s AI governance framework, establishing principles, decision criteria, and guardrails to ensure patient safety, regulatory defensibility, and appropriate AI use across the product lifecycle (aligned with Trudell Medical Ltd.’s AI governance)

Establish risk-based thresholds and decision gates for the design, release, modification, and retirement of AI-enabled features, enabling teams to determine when AI functionality is safe and compliant to ship and how it should mature

Own determination of SaMD classification, intended use, and regulatory impact of AI-enabled functionality, including assessment of significant changes requiring regulatory notification or submission

Collaborate with Compliance, Privacy, Product, Engineering, and Executive leadership on AI-related incident response, external disclosures, and risk mitigation to ensure alignment with enterprise risk management requirements

Establish post-market oversight including complaint management, vigilance reporting, surveillance, clinical follow-up, system reliability and data integrity monitoring (AI-related to include monitoring of model performance, clinical safety signals, data integrity risks, and unintended consequences for patients and clinicians)

Maintain continuous audit readiness for FDA inspections (QSIT framework), Health Canada inspections, customer audits (health system due diligence)

Lead regulatory interactions: pre-submission meetings, 510(k) submissions or other pathways, responses to queries

Qualification

Regulatory AffairsQuality Management SystemsSoftware as a Medical DeviceAI/ML GovernanceRisk ManagementHealthcare InteroperabilityAgile MethodologiesCollaborationOrganizational SkillsLeadership

Required

Bachelor's degree in Engineering, Life Sciences, Health Sciences, Computer Science, or a related field

Minimum of 8+ years of progressive experience in Regulatory Affairs and Quality within digital health, SaMD, or regulated healthcare technology environments

Demonstrated experience building regulatory and quality systems in early- to mid-stage organizations (seed through Series B preferred). Must be comfortable with ambiguity, rapid iteration, and resource constraints

Hands-on experience supporting SaMD products across full lifecycle including product definition, development, deployment, and post-market activities

Experience applying risk-based, phased regulatory approaches aligned to product maturity — demonstrable ability to articulate 'threshold excellence' and defend scope decisions

Prior experience with regulatory interactions, audits, or inspections (FDA, Health Canada, notified bodies) with successful outcomes

Experience working closely with product, engineering, and clinical teams in agile environments — must embed within cross-functional teams, not operate in isolation

Strong working knowledge of SaMD regulatory frameworks (primarily US)

Expertise in AI/ML regulatory requirements

Familiarity with cybersecurity, privacy, and data governance

Understanding of healthcare interoperability standards

Understanding of regulatory considerations unique to remote care delivery: distributed users, system reliability/uptime, complaint handling at scale, remote onboarding/training

Proven hands-on leadership owning both strategy and execution — writing SOPs, conducting risk assessments, reviewing design documentation, performing audits

Strong judgment in environments with evolving requirements and incomplete information — ability to make defensible, risk-based calls without perfect data

Ability to translate complex regulatory concepts into clear, actionable guidance for non-regulatory stakeholders

Collaborative, low-ego leadership — influence through expertise and trust rather than authority. Thrives in flat hierarchies with direct communication

Strong organizational skills managing multiple priorities while maintaining audit readiness