ResMed
Senior Engineer in Compliance for SaMD
Job Description
Drive innovation as a Senior Compliance Engineer at Resmed, specializing in Software as a Medical Device. Work alongside engineering teams to enforce compliance with industry standards.
In this role, you will act as a compliance authority within the Digital Engineering Product Development organization. Your responsibilities include managing audits, crafting risk management plans, and ensuring product specifications align with both regulatory and safety requirements. This position offers a chance to make a tangible impact on healthcare software solutions.
Key Responsibilities:
• Lead as the SME for compliance audits on your products
• Create and maintain Risk Management Plans as needed
• Manage specifications and ensure effective traceability
• Lead technical design evaluations for new products
• Handle post-market risk assessments on software defects
Requirements:
• Bachelor's or Master's in engineering or science
• 4-5 years in the medical device product ...
In this role, you will act as a compliance authority within the Digital Engineering Product Development organization. Your responsibilities include managing audits, crafting risk management plans, and ensuring product specifications align with both regulatory and safety requirements. This position offers a chance to make a tangible impact on healthcare software solutions.
Key Responsibilities:
• Lead as the SME for compliance audits on your products
• Create and maintain Risk Management Plans as needed
• Manage specifications and ensure effective traceability
• Lead technical design evaluations for new products
• Handle post-market risk assessments on software defects
Requirements:
• Bachelor's or Master's in engineering or science
• 4-5 years in the medical device product ...