Vice President, QA & Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Provides strategic direction for Quality Assurance and Regulatory Affairs in a Software as a Medical Device (SaMD) setting.

• Guarantees adherence to FDA 21 CFR Part 820, EU MDR, ISO 13485, ISO 14971, IEC 62304, and IEC 62366.

• Advances quality and regulatory strategies within an Agile/SAFe development lifecycle while facilitating continuous delivery and ensuring compliance.

• Engages in the formulation and implementation of both short-term and long-term organizational strategies.

• Directs and coordinates a high-performance team to accomplish established strategies.

• Acts as the organization's representative to external regulatory bodies.

• Evaluates proposed modifications to standards and regulations, ensuring that procedures and policies align with accrediting and licensing requirements.

• Oversees and mitigates business risks.

• Ensures that division expenditures stay within the approved annual budget.

• Keeps abreast of significant developments and trends in the healthcare industry.

• Collaborates with Product Management, Engineering, and Architecture within a SAFe Agile Release Train framework.

• Integrates quality and regulatory compliance into PI Planning, backlog refinement, and sprint execution.

• Establishes and sustains a digital Quality Management System (eQMS).

• Ensures traceability from user requirements through to validation evidence.

• Promotes continuous compliance and risk-based validation strategies in line with SAFe cadence.

• Acts as a key quality authority within Agile teams without causing delivery delays.

• Facilitates cross-functional alignment among QA, Engineering, Regulatory, and Product teams.

• Develops scalable QA/RA processes to support rapid software release cycles.

⛳️ Requirements

• Bachelor’s degree in medical technology, Healthcare, Chemistry, Biology, Biotechnology, or a related field from an accredited institution.

• At least fifteen (15) years of progressively responsible management and leadership experience in quality & regulatory affairs, ideally within a blood bank environment.

• An equivalent combination of education, certification, training, and/or experience will be considered.

• Preferred qualifications include AAMI Quality System Requirements and Industry Practice (QSR), AAMI Human Factors for Medical Devices, Certified Software Quality Analyst (CSQA), or Certified Software Tester (CSTE).

• Blood bank certification programs are an advantage.

• Demonstrated ability to act with integrity and exemplify that behavior for others.

• Experience collaborating with Product Management, Engineering, and Architecture within a SAFe Agile Release Train (ART) framework.

• Familiarity with PI Planning, backlog refinement, and sprint execution.

• Proven ability to establish and maintain a digital Quality Management System (eQMS).

• Understanding of traceability from user requirements to system requirements to test cases to validation evidence.

• Knowledge of risk management principles related to software design and release cycles.

• Willingness to commute and travel as required.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and flexible work arrangements.

• Opportunities for professional development and continuing education.

• Collaborative and inclusive work environment.