Regulatory & Quality Affairs Manager
Core
Lead global regulatory strategy and quality operations for Software as a Medical Device (SaMD) products, ensuring compliance with international regulations throughout the product lifecycle.
Role type
Senior Regulatory & Quality Affairs Manager
Builds
SaMD products for deep-learning medical imaging analytics targeting chronic and acute diseases (via careerplan.io/jobs/43-00F-7F-F6F-regulatory-quality-affairs-manager-at-nanox)
Domain
Medical device industry + AI/ML regulatory compliance
Deliverable
production ML models
Required skills
SaMD regulation expertise, US 510(k) and EU-MDR submission experience, QMS implementation (ISO 13485, FDA 21 CFR Part 820), risk management, clinical evaluation, SDLC with ML, cybersecurity regulations, cross-functional leadership
Preferred skills
Certified ISO 13485 Auditor, experience with ISO 62304 and ISO 14971
Technologies
None explicitly listed beyond regulatory frameworks
Responsibilities
Lead RA/QA in SaMD device submissions (US 510(k), CE), coordinate regulatory and quality inspections/audits, communicate with regulatory bodies, develop and maintain QMS, prepare product development documents, conduct management reviews and data analysis, manage risk management process, plan company training and onboarding
Seniority
Senior, hands-on IC