Drive compliance and innovation as a Senior Compliance Engineer at ResMed in Halifax or San Diego. Join a team dedicated to developing Software as a Medical Device for healthcare solutions.
In this full-time role, you will partner with software engineering to ensure compliance with medical device regulations and cybersecurity standards. Your expertise will guide internal audits, risk management plans, and technical design reviews, ensuring the highest level of product trustworthiness. You will play a pivotal role in producing documentation and assessing software library inclusions to meet industry requirements.
Key Responsibilities:
• Act as primary SME for internal and external audits
• Create and manage Risk Management Plans
• Lead technical design reviews for new product introductions
• Perform post-market risk assessments on products
• Draft gap analyses for updated regulations
Requirements:
• BS/MS in engineering or scientific discipline
• 4-5 years e...