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Posted 6 months ago
Requirements and responsibilities
About LumafieldLumafield was founded in 2019 to upgrade manufacturing.We are engineers with deep experience across the product development cycle, from initial ideas to shipping hardware, across industries and specializations, who became frustrated by the cost and complexity of modern manufacturing. So we decided to upgrade it.Engineers make million-dollar decisions every day, and they need tools that give them the greatest possible insight into their products. By offering unprecedented visibility into products, as well as AI-driven tools that highlight problems and generate quantitative data, Lumafield promises to revolutionize the way complex products are created, manufactured, and used across industries. We started with industrial CT scanning, which for us was the most valuable but underutilized tool in the manufacturing toolbox, enabling us to rapidly inspect essential components non-destructively.We rebuilt the whole system, from X-ray capture, to computer vision analysis, to web-based collaboration, to the entire business model, making the most advanced manufacturing tech more accessible to every industry. Our company, like our platform, is designed for upgrades. We’re building for greater intelligence, autonomy, and speed. For deeper vision, operational excellence, and powerful insights. And then we'll upgrade it all again.Lumafield is headquartered in Cambridge, MA, and has an office in San Francisco, CA.About the roleLumafield is looking for a Regulatory Affairs Specialist to help Lumafield and its customers meet the regulatory requirements associated with our cutting edge hardware-software products. You’ll translate global regulatory requirements into clear, engineering-ready actions and build the right-sized processes that let a growth-stage hardware company move fast without cutting corners. You’ll drive regulatory and compliance excellence across the full lifecycle: onboarding and training; product research and design; manufacturing and shipping; on-site installation and maintenance; and customer training.You will work across teams to address real problems and make our technology safe, secure, and accessible for our customers.Lumafield is changing the way the world makes everything. If you are interested in joining a well-funded growth stage company and having a significant impact on innovative hardware products, this is the perfect opportunity for you to become a part of the Lumafield team!What you'll doAct as a regulatory representative both internally and externally.Identify regulations we must comply with in the design, manufacture, sale, and service of our products.Work with our engineering, manufacturing, sales, and fleet operations teams to ensure we maintain strict compliance.Identify regulations that apply to customers.Plan and coordinate product approval testing for global markets.Prepare and submit regulatory applications.Prepare and maintain records and documentation such as registrations, device listings, state manufacturing licenses, etc.Coordinate with consultants, vendors and experts as required.About youHave experience or expertise in: risk analysis, quality system requirements, verification/validation testing.Are organized and detail-oriented.Can handle situations where the SOP is a draft (or you’re writing it as you go).Are comfortable giving and taking instructions for work in a team environment.Enjoy collaborating within and across teams.Have strong communications skills, and can effectively communicate across the organization from technicians, executives, software engineers and hardware designers.Can demonstrate good technical writing skill.Bonus points forExperience with industrial X-ray or radiation-based systems.Salary$75,000 - $90,000 a year
Optionally, you can add more information later (benefits, pre-screening questions, etc.)