Senior Compliance Engineer

The Digital Engineering Product Development organization is looking for a Senior Compliance Engineer to help develop SaMD and health software applications for Resmed customers and patients.

Requirements

• BS/MS in any engineering or scientific discipline. Computer science preferred. No hands-on coding experience is needed.
• At least 4-5 years of working in the medical device or pharmaceutical industry, preferably in medical device product development.
• At least 3-5 years of experience in audits with criteria such as ISO 13485, EU MDR, MDSAP, HDS, SOC2, HITRUST and other regulatory frameworks.
• Proficiency in producing technical analysis/reports, including ability to learn about and understand clinical pathways.
• Thorough understanding of medical device regulations and standards.
• Solid technical knowledge of the software development lifecycle and common industry tools and methods.
• Basic familiarity with privacy laws (EU GDPR, CCPA, HIPAA)

Benefits

• Supportive environment that focuses on people development and best practices
• Opportunity to design, influence, and be innovative
• Work with global teams and share new ideas
• Be supported both inside and outside of the work environment
• The opportunity to build something meaningful and seeing a direct impact on people's lives