# Regulatory Affairs & Quality Assurance Specialist The Ark · Hybrid at Chipiron

- Company: Chipiron
- What the company does: 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.
- Company website: https://chipiron.co
- Type: Startups
- Level: Mid level
- Location: Remote (US)
- Work setup: Remote
- Posted: 2026-07-08
- Apply by: 2026-10-12
- Apply: https://jobs.chipiron.co/jobs/8041060-regulatory-affairs-quality-assurance-specialist
- Page: https://www.1752.vc/careers/jobs/chipiron-regulatory-affairs-and-quality-assurance-specialist-the-ark-hybrid/

## 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