Quality Assurance and Regulatory Affairs Vice President - QA & Regulatory Affairs

Overview

Provides strategic leadership for Quality Assurance and Regulatory Affairs in a Software as a Medical Device (SaMD) environment. Ensures compliance with applicable regulations including 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

Responsibilities

The list of essential functions, as outlined herein, is intended to be representative of the duties and responsibilities performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position.

• Participates in the development and execution of the organization's short term and long-term strategies
• Motivates and leads a high-performance team, ensuring that the division is appropriately organized and staffed to achieve the approved strategies
• Represents the organization to external regulatory agencies
• Reviews proposed changes to standards and regulations; ensures procedures and policies meet accrediting and licensing agencies requirements
• Creates and environment to meet or achieve stated business and quality goals and objectives
• Ensures that risks to the business are being monitored and managed
• Ensures that the expenditures of the division are within the authorized annual budget
• Maintains a working knowledge of significant developments and trends in the healthcare industry

Qualifications

QUALIFICATIONS:To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

EDUCATION AND/OR EXPERIENCE:

Bachelor’s degree in medical technology, Healthcare, Chemistry, Biology, Biotechnology or related field from an accredited college or university; Master’s degree preferred. Minimum of fifteen (15) years of progressively responsible management and leadership in quality & regulatory affairs, preferably in a blood bank environment; or an equivalent combination of education, certification, training, and/or experience.

CERTIFICATES, LICENSES, REGISTRATIONS AND DESIGNATIONS:

AAMI Quality System Requirements and Industry Practice (QSR), AAMI Hunman Factors for Medical Devices, Certified Software Quality Analyst (CSQA) or Certified Software Tester (CSTE) preferred.  Blood bank certification programs a plus

KNOWLEDGE, SKILLS AND ABILITIES:

• Ability to act with integrity and model that behavior for others
• Participates int he development and execution of organizational strategies
• Partners with Product Management, Engineering, and Architecture within a SAFe Agile Release Train (ART) structure
• Ensures quality and regulatory compliance are built into PI Planning, backlog refinement, and sprint execution
• Establishes and maintains a digital Quality Management Systems (eQMS)
• Ensures traceability from user requirements to system requirements to test cases to code to validation evidence
• Drives continuous compliance
• Applies risk management principles to software design and release cycles
• Maintains risk traceability across Agile iterations and releases
• Serves as a Key quality authority within Agile teams without creating delivery bottlenecks
• Enables cross-functional alignment between QA, Engineering, Regulatory, and Product
• Drives adoption of risk-based validation strategies aligned with SAFe cadence
• Enables scalability of QA/RA processes for rapid software release cycles
• Ability to commute and travel as needed.

PHYSICAL REQUIREMENTS:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Ability to exert light physical effort in sedentary to light work, which may involve some lifting, carrying, pushing and/or pulling of objects and materials of light weight (up to 20 pounds).

ENVIRONMENTAL REQUIREMENTS:The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job.

Functions are regularly performed inside without potential for exposure to adverse conditions, such as inclement weather, atmospheric elements and pathogenic substances.