The Role

The mission of the Q&R Director is to establish and maintain an effective and efficient quality system that assures Akili products, processes and services exceed customer and regulatory compliance expectations.

Responsibilities

• Manage the quality and regulatory compliance aspects of the Akili Quality System in accordance with applicable target market requirements
• Ensure all products and operations consistently meet or exceed applicable target market requirements
• Coordinate the internal and external assessments of the Akili Quality System
• Establish and maintain key processes (CAPA, Risk Management, Complaint handling) to ensure they are managed effectively and in a timely manner
• Partner with key stakeholders in the areas of product development, marketing, sales, and clinical to provide direction and consultation
• Provide Quality Engineering support through the review and approval of product and services documentation in accordance with applicable requirements, the risk management process, and the Akili Quality System
• Lead the change and improve efforts of the Akili Quality System to ensure continuous improvement
• Provide Quality Engineering support through the review and approval of product and services documentation in accordance with applicable requirements, the risk management process, and the Akili Quality System
• Champion software tool validations for applicable product and process based automation assets
• Assist with regulatory submissions, clinical trial management, and regulatory requests as required

Qualifications

• A Bachelors, Masters, or PhD in a technical discipline (engineering, computer science, or similar) with a minimum of 10 years direct experience managing quality and regulatory in a regulated life sciences industry
• Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR 803, 806, 812, and 820, ISO 13485, 14971, 62304, 82304, MDD and MDR, and Japanese MHLW Ordinance 169
• Experience with SaMD, Software as a service, and digital health a plus 
• Excellent verbal and written communication in English
• A demonstrated track record of solving problems and working in a team based environment

About Akili

At Akili Interactive, our mission is to ignite new hope for those living with cognitive impairment.  We’re bringing together world-class neuroscience with the latest technology and video game entertainment to create a new class of digital medicines, delivered through captivating video game experiences.  We are out to prove that effective medicine for serious illnesses can also be fun and engaging.

Our flagship product, EndeavorRx, is the first ever FDA-cleared prescription treatment delivered through a video game to treat children living with ADHD.  This is only the beginning, as we continue to boldly challenge the status quo of today’s medicine.  

Diversity and Inclusion

Diversity and inclusion are incredibly important to all of us.  We are committed to hearing all voices.  Akili Interactive provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, genetics, sexual orientation, gender identity or gender expression.