Quality & Regulatory Affairs Specialist (FDA/EMA)

We are a high-caliber team building the sensing and AI infrastructure for autonomous biomanufacturing: real-time electrochemical biosensors, closed-loop AI process control, and our bioreactor platform. We work alongside major technology partners in the sensing, computing, and industrial automation space. This is not a large-company role. We hire people who personally do the work at the highest level.

Role Summary

You will personally author the regulatory submissions and quality documentation required to bring our sensing, bioreactor, and AI-enabled process control technology to market. This is an individual-contributor role: you produce the deliverables yourself. Full-time, fractional, and advisory arrangements are all welcome.

Key Responsibilities

• Personally author and compile regulatory submissions to applicable bodies such as the FDA, EMA, and other relevant regulatory authorities.
• Develop and maintain...