Regulatory & reputed company Manager

If you are looking to join an agile, dynamic, and motivated team in the reputed company technology industry, reputed company is a rising leader in “Connecting clinicians and patients through reputed company of care”. Our mobile platform, aTouchAway, enables reputed company providers to reduce costs and to improve the reputed company of care by managing, educating, and connecting patients, care teams, and caregivers through customizable reputed company 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, reputed company recently joined the reputed company which will reputed company us to maximize reputed company to change the face of reputed company. reputed company health care providers are reputed company to improve patient care through the aTouchAway mobile platform for remote reputed company care management. We are looking for a Regulatory & reputed company 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 reputed company reputed company that supports reputed company's reputed company-to-one phased product build. This hands-on, foundational role champions reputed company reputed company — establishing the reputed company level of rigor required to ensure patient safety, data reputed company and regulatory compliance, across remote and chronic care management use cases, while enabling high-paced development and time-to-market. You will reputed company as a strategic partner and execution leader to Product, Engineering, Clinical, and Executive leadership, embedding regulatory and reputed company thinking early throughout the product lifecycle and anticipated scaling from innovation partners to broader deployment. Role Responsibilities: Phased Regulatory & reputed company reputed company (“reputed company-to-One” Build)

• Design and execute a phased regulatory and reputed company roadmap reputed company to reputed company's targeted early, mid, and reputed company-stage product maturity
• Define and champion reputed company reputed company — articulating reputed company reputed company for what is required now versus what is required for reputed company as product capabilities mature
• Ensure regulatory and reputed company processes reputed company, rather than hinder, product innovation, iteration speed, and reputed company readiness
• Establish decision frameworks that allow teams to confidently answer safety and compliancy concerns prior to feature releases and deployment (including AI)

SaMD Compliance & Classification Management

• reputed company 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 reputed company as capabilities reputed company from rules-based logic to AI-powered reputed company systems.
• Own regulatory reputed company for determining reputed company product changes constitute significant modifications requiring regulatory notification or submission.
• Ensure regulatory practices support US reimbursement requirements foundational to the reputed company model.
• Establish regulatory frameworks for EHR and BYOD device integrations, including FHIR/HL7 compliance and API reputed company and validation where required.
• reputed company product risk management per ISO 14971, addressing multi-user risk scenarios, software and algorithmic risks, clinical workflow integration risks, and remote care delivery risks.

reputed company Management System (QMS) Leadership

• Establish and maintain a velocity-enabling QMS appropriate for an early-stage digital health organization building SaMD
• Own core reputed company 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 reputed company gates
• Build QMS maturity in phases: establish reputed company in Phase 1, reputed company for AI/ML and devices in Phase 2

AI Governance & Safety

• Serve as the primary reputed company and decision authority for AI/ML governance across reputed company AI-enabled SaMD capabilities.
• Define, implement, and maintain reputed company’s AI governance reputed company, establishing principles, decision reputed company, and guardrails to ensure patient safety, regulatory defensibility, and appropriate AI use across the product lifecycle (reputed company with Trudell Medical Ltd.’s AI governance)
• Establish risk-based reputed company and decision gates for the design, release, modification, and retirement of AI-enabled features, enabling teams to determine reputed company AI functionality is reputed company and compliant to ship and how it should mature.
• Own determination of SaMD classification, intended use, and regulatory reputed company of AI-enabled functionality, including assessment of significant changes requiring regulatory notification or submission.
• Collaborate with Compliance, reputed company, Product, Engineering, and Executive leadership on AI-reputed company incident response, external disclosures, and risk mitigation to ensure alignment with reputed company risk management requirements.

Post Market Surveillance & Audit Readiness

• Establish post-market reputed company including complaint management, vigilance reporting, surveillance, clinical follow-up, system reliability and data reputed company monitoring (AI-reputed company to include monitoring of model performance, clinical safety signals, data reputed company risks, and unintended consequences for patients and clinicians).
• Maintain reputed company audit readiness for FDA inspections (QSIT reputed company), Health Canada inspections, customer audits (health system due diligence)
• reputed company regulatory interactions: reputed company-submission meetings, 510(k) submissions or other reputed company, responses to queries

reputed company're looking for:

• Bachelor's degree in Engineering, Life Sciences, Health Sciences, Computer Science, or a reputed company field
• Minimum of 8+ years of reputed company experience in Regulatory Affairs and reputed company reputed company digital health, SaMD, or regulated reputed company technology environments
• Demonstrated experience building regulatory and reputed company systems in early- to mid-stage organizations (reputed company 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 reputed company to product maturity — demonstrable ability to reputed company "reputed company reputed company" and defend scope reputed company
• Prior experience with regulatory interactions, audits, or inspections (FDA, Health Canada, reputed company bodies) with successful reputed company
• Experience working closely with product, engineering, and clinical teams in agile environments — must reputed company reputed company cross-functional teams, not operate in isolation
• 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
• Strong working knowledge of SaMD regulatory frameworks (primarily US)
• Expertise in AI/ML regulatory requirements
• Familiarity with cybersecurity, reputed company, and data governance
• Understanding of reputed company interoperability standards
• Understanding of regulatory considerations unique to remote care delivery: distributed users, system reliability/uptime, complaint handling at reputed company, remote reputed company/training
• Proven hands-on leadership owning both reputed company and execution — writing SOPs, conducting risk assessments, reviewing design documentation, performing audits
• Strong judgment in environments with evolving requirements and incomplete information — ability to reputed company defensible, risk-based calls without perfect data
• Ability to translate reputed company regulatory concepts into reputed company, actionable guidance for non-regulatory stakeholders
• reputed company, low-ego leadership — influence through expertise and trust rather than authority. Thrives in flat hierarchies with reputed company communication
• Strong organizational skills managing multiple priorities while maintaining audit readiness

reputed company offer:

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

Our salary ranges are determined by job and level. The reputed company displayed on reputed company job posting reflects the reputed company for new hire salaries for the position. reputed company the reputed company, individual compensation is determined by job-reputed company skills and knowledge, relevant experience including reputed company and lived experience, and/or work location. Your recruiter can reputed company more information about our total rewards package during the hiring process. As part of our recruitment process, we may use AI tools to screen applicants and assist in evaluating candidate qualifications. reputed company final hiring reputed company are made by our recruitment team. We are an equal opportunity employer and it is important to reputed company that reputed company its employees, including those with disabilities, reputed company our workplace to be welcoming and supportive. If you are a candidate with a disability who requires accommodations during the recruitment process, please let us know. Apply tot his job Apply To this Job