A medical technology startup developing and commercializing AI-powered Software as a Medical Device (SaMD) is looking for a hands-on QA /RA Manager.
This is an individual contributor role, responsible for maintaining quality management systems, ensuring regulatory compliance, and supporting software development processes in a regulated medical environment.
Responsibilities:
Manage and maintain the company's Quality Management system (QMS), ensuring compliance with applicable FDA and ISO standards.
Oversee quality processes throughout the Software Development Life Cycle (SDLC), including software verification and validation.
Manage quality documentation, change control processes, CAPA, and risk management activities.
Conduct internal audits and coordinate external regulatory and certification audits.
Requirements: 3-5 years of experience in Quality Assurance and Regulatory Affairs within the medical device industry, preferably with SaMD.
Proven hands-on experience managing QMS in accordance with ISO 13485, FDA QMSR, and ISO 14971.
Strong knowledge of IEC 62304 and medical software development processes (SDLC).
Experience conducting internal audits and managing external audits.
Hands-on experience using AI tools such as Claude, ChatGPT, and similar platforms in daily workflows - a must.
This position is open to all candidates.