ResMed is seeking a Senior Compliance Engineer to support the development of software as a medical device (SaMD) and health software applications. The role involves ensuring compliance with medical device regulations and cybersecurity standards while collaborating with software engineering teams
Job Summary
The role involves acting as the primary Subject Matter Expert for internal and external audits on assigned medical device products.
Candidates will create Risk Management Plans and perform safety and security risk analysis in collaboration with engineering and medical affairs teams.
The position offers an opportunity to build meaningful health technology solutions within a supportive, innovation-driven global environment.
Matching Summary
Match Score: 85
ResMed is seeking a Senior Compliance Engineer to support the development of software as a medical device (SaMD) and health software applications. The role involves ensuring compliance with medical device regulations and cybersecurity standards while collaborating with software engineering teams.
Skills & Requirements
Must-have
ISO 13485 regulatory compliance expertise
EU MDR and MDSAP audit experience
SaMD risk management plan creation
Cybersecurity regulatory requirements knowledge
Technical design review leadership
Nice-to-have
Understanding of clinical pathways
Experience with SOC2 and HITRUST frameworks
Familiarity with EU GDPR and HIPAA privacy laws
Ability to influence product design processes
Collaboration with global engineering teams
Key Requirements
BS/MS in engineering or scientific discipline
4-5 years in medical device or pharmaceutical industry
3-5 years of experience with ISO 13485 and EU MDR audits
Proficiency in producing technical analysis reports
Solid understanding of software development lifecycle