Regulatory & Quality Manager

Trudell Medical Group • Minneapolis, MN

27d • Remote

About The Position

If you are looking to join an agile, dynamic, and motivated team in the healthcare technology industry, Aetonix is a rising leader in “Connecting clinicians and patients through pathways of care”. Our mobile platform, aTouchAway, enables healthcare providers to reduce costs and to improve the quality of care by managing, educating, and connecting patients, care teams, and caregivers through customizable healthcare protocols, remote patient monitoring, and telehealth. Today, our platform is used by tens of thousands of patients in hundreds of hospitals, but this is just the start.
Beginning as a start-up 10 years ago, Aetonix recently joined the Trudell Medical Group which will enable us to maximize the opportunity to change the face of Healthcare. Professional health care providers are able to improve patient care through the aTouchAway mobile platform for remote complex care management.
We are looking for a Regulatory & Quality Manager located in the Minneapolis, Minnesota area.
This is a remoted based role.
Reporting to the President, you will be responsible for leading, establishing and executing a velocity-enabling, pragmatically rigorous regulatory and quality strategy that supports Aetonix's zero-to-one phased product build. This hands-on, foundational role champions threshold excellence — establishing the optimal level of rigor required to ensure patient safety, data integrity and regulatory compliance, across remote and chronic care management use cases, while enabling high-paced development and time-to-market.
You will act as a strategic partner and execution leader to Product, Engineering, Clinical, and Executive leadership, embedding regulatory and quality thinking early throughout the product lifecycle and anticipated scaling from innovation partners to broader deployment.

Requirements

• 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

Nice To Haves

• Experience in remote care management, CCM, RPM, or digital clinical workflows strongly preferred.
• Startup experience preferred — comfort with ambiguity, rapid pivots, resource constraints, wearing multiple hats, and building from scratch

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

Benefits

• An agile, dynamic and motivated team working together in a fast-growing company that is changing the future of virtual care
• The ability to make a real difference in people’s lives
• Health insurance including medical, dental, vision and life

What This Job Offers

• Job Type: Full-time
• Career Level: Manager