focusing on design and pre-market activities. Acting as a trusted partner to R&D and Regulatory Affairs, you will help drive informed decision-making that safeguards patients while enabling compliant innovation. Key Responsibilities Design & Development Quality Leadership Champion critical thinking across product development teams throughout all stages … analyses, FMEAs, and related risk management documentation. Ensure risk control measures are implemented, verified, and supported by objective evidence. Provide structured, risk-based decision-making to support product safety and compliance. Ensure riskbenefit evaluations are complete, clear, and aligned with global regulatory expectations. Material Review Board (Design-Related ...