Compliance Engineering Expert for Healthcare Software

Join Resmed as a Senior Compliance Engineer, focused on ensuring the safety and compliance of health software applications. Collaborate with engineers to uphold strict regulatory standards. You will function as a key player in the Digital Engineering Product Development team, liaising with software engineers to define compliance-driven product designs.

Your role encompasses overseeing audits, drafting gap analyses on regulations, and managing comprehensive documentation crucial for successful product launches and updates. Key Responsibilities: • Serve as the SME during internal and external audits • Develop Risk Management Plans with software engineering teams • Oversee product specification management and traceability • Lead design reviews for product changes and new releases • Draft comprehensive documentation for regulatory compliance Requirements: • BS/MS in any engineering or scientific field • Minimum 4-5 years in medical device or pharma sectors • At least 3-5 years of experience with ISO audit criteria • Strong ability to produce and analyze technical reports • Basic understanding of privacy regulations like HIPAA Leverage your expertise to influence design and compliance, ensuring patient safety through innovative software development at Resmed. #J-18808-Ljbffr