Regulatory & Quality Affairs Manager
Core
Lead global regulatory strategy and quality operations for Software as a Medical Device (SaMD) products, ensuring compliance with international standards throughout the product lifecycle.
Role type
Senior Regulatory & Quality Affairs Manager
Builds
SaMD products for medical imaging analytics targeting chronic and acute diseases (via careerplan.io/jobs/43-00F-7F-F6F-regulatory-quality-affairs-manager)
Domain
Medical device industry + AI/Deep Learning
Deliverable
client delivery
Required skills
Global regulatory strategy, SaMD lifecycle management, QMS implementation, Risk management, Clinical evaluation, Cross-functional leadership, Technical documentation, Audit preparation, Training delivery
Preferred skills
ISO 13485 Auditor certification, Machine Learning SDLC knowledge, Cybersecurity regulations expertise
Technologies
FDA 21 CFR Part 820, ISO 13485, EU-MDR, ISO 62304, ISO 14971, ISO 27001, GDPR, HIPAA
Responsibilities
Lead RA/QA submissions (US 510(k), CE), coordinate internal/external audits, develop and maintain QMS, manage risk processes, prepare product development documents, conduct management reviews and data analysis, plan company training and onboarding
Seniority
Senior, hands-on IC with leadership responsibilities