Medical Device R&D and Regulatory Specialist

Join a pioneering initiative to create realistic enterprise environments for training and evaluating frontier AI agents. As a Medical Devices Expert, you will leverage your extensive experience from Fortune 500 medical device manufacturers to design and build high-fidelity digital workspaces that reflect the complexities of regulated medical-device enterprises. Your insights will directly influence the development of tasks that challenge cutting-edge AI technologies.

• Construct a realistic digital workspace using your daily operational tools, including design history files, regulatory submissions, and validation protocols, while incorporating relevant platforms like ANSYS Fluent and Siemens Opcenter MES.
• Develop multi-step tasks based on your actual workflows that require interaction with various applications, files, and stakeholders, effectively challenging frontier AI agents.
• Collaborate with other medical-device professionals to design the environment, define task scope, and review scenarios for accuracy and rigor.
• Engage asynchronously with research teams to refine task designs and establish evaluation criteria for medical-device agent benchmarks.
• Contribute to advanced AI research and benchmarking, with your work informing how leading labs train and evaluate next-generation AI systems.

• Minimum of 3 years of full-time experience at a Fortune 500 medical-device manufacturer or large Tier-1 contract developer/manufacturer.
• Expertise in areas such as regulatory affairs (510(k), PMA, De Novo, EU MDR), quality engineering/eQMS, R&D or design controls, manufacturing engineering, or clinical affairs.
• Certifications such as RAC, ASQ CQE/CRE/CBA are advantageous.
• Proficient in tools like ANSYS Fluent, Siemens Opcenter, and DocuSign.
• Strong analytical thinking and writing skills, capable of translating regulated-device workflows into structured task specifications.

This project will initially offer an effective hourly rate, transitioning to a compensation model based on the throughput of quality work.

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