Vice President, QA & Regulatory Affairs

ARC-One Solutions

. Provides strategic leadership for Quality Assurance and Regulatory Affairs in a Software as a Medical Device (SaMD) environment .

Posted 11/11/2026full-timeRemote • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Quality Assurance and Regulatory Affairs within a Software as a Medical Device (SaMD) environment, ensuring compliance with relevant regulations and driving quality strategies in Agile development lifecycles.

Highest-signal resume keywords

Quality Assurance LeadershipRegulatory Compliance ExpertiseAgile/SAFe Development MethodologiesDigital Quality Management System (eQMS)Risk Management Principles

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

FDA 21 CFR Part 820EU MDRISO 13485ISO 14971IEC 62304IEC 62366Traceability ManagementContinuous Compliance StrategiesQuality System Requirements (QSR)Human Factors for Medical Devices

Soft Skills

IntegrityLeadershipCross-Functional CollaborationStrategic PlanningTeam Organization

Tools & Technologies

Digital Quality Management System (eQMS)SAFe Agile Release Train (ART)PI PlanningBacklog RefinementSprint Execution

Certifications & Qualifications

Certified Software Quality Analyst (CSQA)Certified Software Tester (CSTE)Blood Bank Certification Programs

Industry Keywords

Healthcare Industry DevelopmentsQuality AssuranceRegulatory AffairsSoftware as a Medical Device (SaMD)Blood Bank Environment

About the role

Key responsibilities & impact

Provides strategic leadership for Quality Assurance and Regulatory Affairs in a Software as a Medical Device (SaMD) environment
Ensures compliance with FDA 21 CFR Part 820, EU MDR, ISO 13485, ISO 14971, IEC 62304, and IEC 62366
Drives quality and regulatory strategy within an Agile/SAFe development lifecycle while enabling continuous delivery and maintaining compliance
Participates in the development and execution of short-term and long-term organizational strategies
Leads and organizes a high-performance team to achieve approved strategies
Represents the organization to external regulatory agencies
Reviews proposed changes to standards and regulations and ensures procedures and policies meet accrediting and licensing requirements
Monitors and manages business risks
Ensures division expenditures remain within the authorized annual budget
Maintains knowledge of significant healthcare industry developments and trends
Partners with Product Management, Engineering, and Architecture within a SAFe Agile Release Train structure
Ensures quality and regulatory compliance are incorporated into PI Planning, backlog refinement, and sprint execution
Establishes and maintains a digital Quality Management System (eQMS)
Ensures traceability from user requirements through validation evidence
Drives continuous compliance and risk-based validation strategies aligned with SAFe cadence
Serves as a key quality authority within Agile teams without creating delivery bottlenecks
Enables cross-functional alignment between QA, Engineering, Regulatory, and Product
Enables scalable QA/RA processes for rapid software release cycles

Requirements

What you’ll need

Bachelor’s degree in medical technology, Healthcare, Chemistry, Biology, Biotechnology or related field from an accredited college or university
Minimum of fifteen (15) years of progressively responsible management and leadership in quality & regulatory affairs, preferably in a blood bank environment
Equivalent combination of education, certification, training, and/or experience accepted
AAMI Quality System Requirements and Industry Practice (QSR), AAMI Human Factors for Medical Devices, Certified Software Quality Analyst (CSQA) or Certified Software Tester (CSTE) preferred
Blood bank certification programs a plus
Ability to act with integrity and model that behavior for others
Experience partnering with Product Management, Engineering, and Architecture within a SAFe Agile Release Train (ART) structure
Knowledge of PI Planning, backlog refinement, and sprint execution
Ability to establish and maintain a digital Quality Management System (eQMS)
Knowledge of traceability from user requirements to system requirements to test cases to code to validation evidence
Knowledge of risk management principles applied to software design and release cycles
Ability to commute and travel as needed