Join ResMed as a Senior Compliance Engineer and lead the development of innovative Software as a Medical Device (SaMD) solutions. Ensure compliance with essential medical device regulations and elevate product safety.
In this senior role, you'll closely collaborate with software engineering teams to influence product design and ensure alignment with regulatory standards. Your responsibilities include conducting audits and risk assessments, as well as managing documentation related to product compliance. Your expertise will ensure our software products meet the highest safety and security qualifications our customers trust.
Key Responsibilities:
• Primary SME for audits of assigned products
• Develop and implement Risk Management Plans
• Oversee product specification management
• Conduct technical design reviews for product launches
• Perform post-market assessments on product incidents
Requirements:
• BS/MS in engineering or a relevant field
• 4-5 years in...