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 quality management system documentation appropriate to our product lines.
Conduct gap analyses against applicable regulations and standards.
Prepare and maintain risk management documentation.
Liaise directly with regulatory bodies, notified bodies, or consultants as needed.
Support customer-facing quality and regulatory inquiries during evaluations and deployments.
Keep the company current on evolving regulatory expectations relevant to AI-enabled and hardware/software combination products in biomanufacturing.
Requirements
Substantial hands-on experience personally authoring regulatory submissions to the FDA and/or EMA.
Strong working knowledge of relevant quality systems (e.g., ISO 13485, GxP, or comparable frameworks).
Ability to work independently and deliver finished regulatory and quality documents without a supporting team.
Comfortable operating in a full-time, fractional, or advisory capacity.
Nice to Have
Experience with combination hardware, software, and AI-enabled products.
Experience with sensors, bioreactors, or process analytical technology (PAT).
Familiarity with emerging regulatory pathways for AI/ML-enabled devices and systems.
We offer
Full-time employment
Competitive salary
Comprehensive Benefits package
RRSP match
A dynamic and engaging work environment
Career development opportunities
Full time/Part time work arrangements may be available based on company needs.
Equal opportunity
At n!Biomachines, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. n! biomachines is proud to be an equal opportunity workplace and we are committed to creating an inclusive environment for all employees.
If you have any accommodation requirements, please let us know. We will do our best to meet your needs in accordance with applicable local legislation.
