The Role
The Regulatory Affairs Specialist ensures compliance with regulations throughout product lifecycle, collaborates across teams, and manages regulatory submissions for Lumafield's hardware-software products.
Summary Generated by Built In
About Lumafield:
Lumafield 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 role:
Lumafield 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 do:
- Act 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 you:
- Have 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 for:
- Experience with industrial X-ray or radiation-based systems.
#LI-LUMAFIELD
This role will be located in Lumafield’s Boston office. You may be required to travel up to 10%, depending on local, state and federal regulations and recommendations pertaining to COVID-19.
Lumafield offers both competitive cash and equity compensation, as well as a health & wellness stipend, 401k, parental leave, flexible PTO, commuter benefits, company wide events and more!
Lumafield is committed to building a team that represents a variety of backgrounds, perspectives, and skills, because the more inclusive we are, the better our work will be. Do you feel like your skills don’t meet every single requirement listed? We encourage you to apply anyway – If you’re excited about our technology, the opportunity, and are eager to learn more we’d love to hear from you!
In keeping with our beliefs and goals, no employee or applicant will face discrimination or harassment based on: race, color, ancestry, national origin, religion, age, gender, marital domestic partner status, sexual orientation, gender identity, disability, genetic information or veteran status.
Reach out if you want to be a part of what we are building.
Top Skills
Quality System Requirements
Risk Analysis
Verification/Validation Testing
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The Company
What We Do
Lumafield is here to make it possible for humanity to solve our hardest problems as quickly as possible.
Lumafield has developed the world's first accessible X-Ray CT scanner for engineers. Lumafield’s easy-to-use scanner and cloud-based software give engineers the ability to see their work clearly, inside and out, at an extremely affordable price.
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.
Founded in 2019, our team includes world-class researchers and industrial designers, PhDs, founders of successful startups, and zero egos.
The company is headquartered in Boston, MA and has an office in San Francisco, CA.
