As Product QA/RA Officer, you are the bridge between innovative engineering and global compliance. You are embedded in the design and development cycle and serve as a strategic guardian of product quality and regulatory requirements.
Responsibilities:
- Design & Development Partnership: Act as the primary QA/RA stakeholder in all product-related design projects. Ensure regulatory requirements are integrated into the product roadmap from inception.
- Technical File Ownership: Compile, maintain, and review Technical Files and Design History Files (DHF) for full compliance with EU MDR, FDA, and other global requirements.
- Post-Market Surveillance & Vigilance: Support product-related complaints and non-conforming products. Lead investigations, conduct root cause analysis, and ensure swift resolution.
- Regulatory Intelligence & Standards: Monitor and analyze evolving technical standards (e.g., AI, Cybersecurity) for portfolio impact. Determine whether product changes require new regulatory submissions or notifications.
- Cross-Functional Guidance: Advise Engineering and Clinical teams on risk management, usability engineering, and software verification/validation strategies.
- Global Submissions Support: Support global market access through high-quality technical documentation for EU MDR, US 510(k), and other international registrations.