Regulatory & Quality Manager

Posted Wednesday, January 14, 2026 at 5:00 AM

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 aTouch

Away, 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 aTouch

Away 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.

• 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 Dev Ops with embedded quality gates
• Build QMS maturity in phases: establish essentials in Phase 1, scale for AI/ML and devices in Phase 2