At Chipiron, we are on a mission to end cancer through scalable MRI technologies. We are building the first light, inexpensive, and open full-body MRI machine that doesn't compromise image quality. Backed by Entrepreneur First.
About the role
Strong sense of ownership: You are comfortable working autonomously, taking full ownership of your missions with an entrepreneurial mindset. Collaborative mindset: You proactively build strong relationships across teams and know how to create alignment in cross-functional environments.
What they're looking for
- Medical or scientific background (Pharmacist, Engineer, Master’s degree in Quality/Regulatory Affairs for medical devices, or equivalent)
- At least 3 years of experience in Quality Assurance and Regulatory Affairs within the medical device industry
- Experience with electromedical devices combining hardware and software is a strong plus
- Strong knowledge of medical device regulations and standards, particularly ISO 13485, FDA regulations, IEC 62304, ISO 14971, and the IEC 60601 series
- Proven experience participating in or leading market approval processes in the US
- Ability to translate regulatory complexity into clear, actionable guidance for diverse audiences
More about this role
We are looking for a hands-on and strategic Regulatory Affairs & Quality Assurance Specialist to help bring our technology from development to global commercialization. You will join our Compliance department (Quality Assurance, Regulatory Affairs & Clinical Affairs) and report to the Head of Compliance. You will work at the intersection of innovation, product development, clinical validation, and regulatory strategy, helping the company move fast while maintaining the highest standards of quality and patient safety.
Medical or scientific background (Pharmacist, Engineer, Master’s degree in Quality/Regulatory Affairs for medical devices, or equivalent).
At least 3 years of experience in Quality Assurance and Regulatory Affairs within the medical device industry.
Experience with electromedical devices combining hardware and software is a strong plus.
Strong knowledge of medical device regulations and standards, particularly ISO 13485, FDA regulations, IEC 62304, ISO 14971, and the IEC 60601 series.
Proven experience participating in or leading market approval processes in the US.
Ability to translate regulatory complexity into clear, actionable guidance for diverse...
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