Quality Assurance & Regulatory Affairs (QA/RA) Specialist - SDLC Focus

This job position is for a Quality Assurance & Regulatory Affairs (QA/RA) Specialist with a focus on Software Development Life Cycle (SDLC). The specialist will be responsible for ensuring the quality and regulatory compliance of software development processes and products.

They will work closely with development teams to implement and monitor QA and regulatory strategies throughout the SDLC phases. This role requires an in-depth understanding of regulatory affairs related to software and medical devices, quality assurance standards, and effective communication skills to collaborate with cross-functional teams.

The successful candidate will contribute to maintaining high-quality standards and compliance with regulatory requirements, supporting the delivery of safe and effective software products.

Key responsibilities include planning and executing quality assurance activities, conducting regulatory research, preparing documentation to meet regulatory requirements, and participating in audits and inspections.

The role is ideally suited for a candidate with experience in software quality assurance, regulatory affairs in medical devices or healthcare software, and familiarity with SDLC methodologies.