Senior Medical Device Quality & Regulatory Engineer
Core
Senior Medical Device Quality & Regulatory Engineer owning QA, QMS, and regulatory infrastructure for a neuromodulation device treating major depressive disorder.
Role type
Senior IC medical device quality & regulatory engineer
Builds
FDA-approved at-home neuromodulation treatment (Flow FL-100)
Domain
Medical devices / Neuromodulation / Mental health
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design control processes, Technical documentation (DHF/DMR), Supplier qualification, ISO 13485 QMS management, Regulatory submissions (FDA/EU MDR), Audit support
Preferred skills
FDA PMA (Class III) experience, Combination hardware/software devices, eQMS/AI tools, Asia-based contract manufacturer experience, Neurotech background
Technologies
ISO 13485, FDA QMSR (21 CFR Part 820), EU MDR, FDA PMA
Responsibilities
Lead Design Control processes, Maintain Technical Files/DHFs/DMRs, Drive supplier qualification and manufacturing quality control, Collaborate on design changes, Support regulatory submissions and audits
Seniority
Senior, hands-on IC
