Senior Artificial Intelligence (AI) Architect

Job Overview

(This role is contingent upon an RFP award and may take weeks to fill.)
We are seeking a dynamic and highly skilled AI Governance Architect to lead the development and implementation of comprehensive governance frameworks for artificial intelligence systems within our organization. This role is pivotal in ensuring that AI solutions adhere to all relevant regulatory standards, ethical guidelines, and industry best practices. The ideal candidate will possess a deep understanding of pharmaceutical and biomedical regulations, along with expertise in managing compliance across complex AI projects. As an AI Governance Architect, you will drive initiatives that promote transparency, accountability, and responsible AI deployment, ultimately safeguarding patient safety and organizational integrity.

Responsibilities

• Design and establish robust AI governance frameworks aligned with FDA regulations, EMA guidelines, ICH standards, and other pertinent health regulation policies.
• Collaborate with cross-functional teams including regulatory affairs, clinical trials, research, and quality assurance to ensure AI systems meet all compliance requirements throughout their lifecycle.
• Develop strategies for regulatory compliance management specific to AI applications in healthcare and pharmaceuticals, including regulatory submissions and risk management protocols.
• Lead efforts in regulatory compliance analysis to identify potential gaps or risks associated with AI models, ensuring adherence to ISO 13485 standards and biomedical regulatory compliance.
• Oversee the preparation and submission of regulatory documents related to AI systems, including FDA submissions and other international regulatory filings.
• Utilize compliance management software to track project milestones, document compliance activities, and maintain audit-ready records for all AI governance initiatives.
• Promote a culture of continuous research and learning by staying current on evolving drug regulation policies, health regulation policies, and emerging standards such as ICH guidelines.

Requirements

• Proven experience in regulatory compliance management within the pharmaceutical or biomedical sectors, with a focus on AI or digital health solutions.
• Strong knowledge of FDA regulations, EMA regulations, ICH guidelines, and drug regulation standards applicable to AI-driven healthcare products.
• Demonstrated expertise in clinical trials processes and the integration of AI systems into regulated clinical environments.
• Familiarity with regulatory affairs practices including regulatory submissions, quality assurance procedures, and risk management strategies.
• Proficiency with compliance management software tools used for tracking projects and maintaining documentation integrity.
• Excellent writing skills for preparing clear, detailed reports and regulatory documentation.
• Strong project management skills with the ability to coordinate cross-functional teams effectively while managing multiple compliance projects simultaneously.
• Knowledge of ISO 13485 standards related to medical devices and biomedical regulatory compliance is highly desirable.
• Data analysis skills to interpret complex datasets related to AI model performance and safety metrics within regulated environments.

Join us as an AI Governance Architect to shape responsible AI deployment in healthcare! Your expertise will be instrumental in advancing innovative solutions while ensuring unwavering adherence to global health regulations—making a meaningful impact on patient safety worldwide!

Pay: $100.00 - $125.00 per hour

Work Location: Hybrid remote in Oklahoma City, OK 73118

Salary : $100 - $125