Vice President, QA & Regulatory Affairs

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👔 Vice President

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ARC-One Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2020

🏥 Healthcare

🏭 Manufacturing

📦 Logistics

Healthcare • Manufacturing • Logistics

ARC-One Solutions is creating a next-generation Blood Establishment Computer Software (BECS) platform designed to support safe, efficient, and compliant regulated blood supply chain management. Formed through a partnership between two of the largest blood centers in the country, ARC-One Solutions plays a crucial role in fulfilling over 50% of the nation’s blood supply needs. With a focus on quality and compliance, their software provides robust solutions for blood collection, manufacturing, and distribution management, ultimately contributing to saving lives.

📋 Description

• 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

• 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

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