Position Overview
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 l...