Co-founder & Chief Regulatory Affairs Officer (CRAO) at Stealth AI Startup

A portfolio company of the AI2 Incubator

About the company:

We power the fourth industrial revolution with AI. We focus on making vast operational, regulatory, and machine telemetry data sources useful to manufacturing operators. We strongly believe that a thriving manufacturing sector is essential to a strong economy, and as technologists, we must contribute to its health and growth. As an early-stage startup, we must tackle many unknowns and risks to deliver on this vision. We are in the gestational stages of building the right team and kickstarting the winning culture to help us take on such a monumental challenge. We seek to build a performance-driven team and culture. We do not fear competition, we take a stance, we are not satisfied with legacy ideas—we innovate with intent. We build and operate morally and ethically but won’t indulge in virtue signaling. We 100% subscribe to AI for good and will not deviate from its core values for technical or commercial gains.  

Position Scope

The role of the CRAO is highly technical, with specific requirements. The ideal candidate will provide internal compliance and quality management program leadership and act as the external point person, subject matter expert, and thought leader to educate the market and customers about the solutions and principles we can deliver. In conjunction with other internal departments, the CRAO will influence product roadmap and vision, help identify key audiences, and establish frameworks for implementing a systematic approach to quality management to ensure adherence to GxP requirements across multiple industries. The Chief Regulatory Affairs Officer will also be responsible for planning and implementing solutions to consulting services to help customers execute an effective internal audit program of all their processes and procedures. The position calls for a visionary that will heavily influence the direction of the company and help oversee all regulatory affairs, including regulatory strategies and guidance based on U.S. and International requirements as defined in FDA Regulations, ISO 13485:2003 Standard, GxP, EPA, and other regulatory bodies across the manufacturing sector at large.

Regulatory Compliance:

• Stay abreast of regulatory requirements and changes, ensuring the organization's compliance with local, national, and international regulations.
• Develop and execute regulatory strategies to help customers facilitate product approvals and certifications.
• Develop, design, and enhance regulatory initiatives to facilitate overall regulatory compliance, preparation of 510(k) premarket notifications, and submissions.
• Oversight of 21 CFR 820.
• Preparation of responses to Regulatory authorities’ supplements, and amendments; participation in final company document review and corrections; preparation of additional information as needed.
• Provide regulatory input to ensure activities follow all appropriate regulations and standards, including but not limited to FDA, ISO 13485:2003, and CMDR.
• Keep apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company and present information as needed.

Quality Management:

• Design management frameworks and product capabilities to integrate with a robust quality management system, including policies, procedures, and documentation to ensure product quality,
• Lead quality improvement initiatives and drive a continuous improvement mindset throughout the organization.
• Ensure the familiarity of all members of the team with correct formats/procedures for labeling. Monitor labeling regulations, external environment, and proposed US regulations/guidance.
• Provide regulatory oversight of changes in manufacturing facilities, processes, procedures, and testing methods.
• Direct internal and external compliance programs, audits, and site inspections by federal and international regulatory agencies. Write and update departmental Standard Operating Procedures.

Team Leadership and Development:

• Lead a high-performing team, providing guidance, mentorship, and professional development opportunities.
• Forster a collaborative and inclusive work environment.

You will love this job if you have:

• Bachelor’s Degree in a related field, master’s preferred
• ISO 13485 Auditor Certification a plus.
• A minimum of 7 years of regulatory and quality assurance.
• An excellent understanding of FDA, FDA QSR 820, GMP’s, drug cGMP, International ISO Standards, ISO 13485, Medical Device Directives (93/42EEC), Canadian Medical Device Regulations & Canadian Submissions.
• Experience in 510K preparation and submission.
• Experience in USFDA and ISO auditing and the ability to prepare and submit documents to FDA, such as 510(k) Premarket Notifications, Premarket Approval Applications, (PMAs), New Drug Applications (NDA).
• Full knowledge of 21 CFR 820.
• Familiarity with OTC pharm registration and submission.

Why you’ll love working with us:

Our founders have strong reputations as thoughtful, forward-thinking colleagues and mentors who cultivate talent. We’ll think intentionally and collaboratively about your career and how we build our team. Our founders’ experiences in workforce development and commitment to diversity, equity, and inclusion are central to our approach. 

• Impact — Our platform will accelerate the pace of scientific discovery and therapy development to advance human health. The opportunity to build something from the ground up, define a new product, and lead a team over time in a space that has a real, positive impact. 
• Early employee impact —. As a member of the very early team, you will play a pivotal role in helping shape our product, team, and culture. For the rest of our days, no matter how many thousands of people join after you, you will always have that honor and distinction. It looks great on a resume, too.
• Early stage equity — A benefit of joining early. None of us (not our founders, nor the Allen Institute for AI Incubator) would be here if we didn’t think that our company will create tremendous value over time. 
• Access to unique learning opportunities — With the Allen Institute for AI Incubator as a cofounder, our team gets access to talks by leading AI researchers/paper authors, access to knowledge sharing amongst the community of hundreds of engineers that work for ai2incubator.com companies, and much more.
• Salary — We are a pre-seed startup and salaries will be modest, and comparative to other pre-seed startups, until we raise. You can expect salary raises that bring you closer to market as we raise money and grow. Plus, you’ll have the energy and excitement of a startup and the unique benefits and learning opportunities of taking an early risk. 
• Flexible location and hours – We are whole people with whole lives and expect that you are, too. We’ll trust each other to make progress as a team, in times and places that work for everyone. Preference for Seattle area. Travel to Seattle will be required from time to time – it’s a beautiful city!
• Visa support - We can provide visa support.

About the AI2 Incubator:

The AI2 Incubator helps entrepreneurs come up with ideas, find co-founders, engage pilot customers, refine their product, work with research paper authors to incorporate the latest A.I. techniques into their technology, and raise millions of dollars in venture funding. They have a strategic relationship with the Allen Institute for A.I.—a world-leading research institute with over 200 A.I. PhDs, researchers, engineers, and support staff—allowing them to dive deep into the latest tech and access one of the most talented groups of researchers.

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