Compliance Engineer - Product Development

Location: IE Dublin, Halifax, Canada

Time Type: Full time

Job Description

We are looking for a Compliance Engineer to support our Product Development teams in either Ireland or in Halifax, Canada.

Let's talk about the team and you:

The Compliance Engineering team is focused on ensuring Resmed's software products, and the processes used to develop them, are compliant with the latest safety, cybersecurity, and privacy standards and regulations. We work closely with the Resmed Digital Engineering Product Development teams to produce safe and secure products, ensure regulatory submissions and audits go smoothly, and improve the efficiency of internal processes with compliance in mind.

Let's talk about responsibilities:

The Compliance Engineer will work with product engineering teams to ensure all regulatory and company requirements are met. The role includes the following core responsibilities:

• Lead critical design control activities including
  • Safety risk analysis
  • Security risk analysis
  • Requirements traceability
  • Design review
  • SOUP/CSV management
• Represent the team in audits, including medical device audits such as MDSAP and EU MDR and security audits such as HITRUST, SOC, and ISO 27001
• Perform gap analyses to new and upcoming compliance standards and regulations
• Make improvements to Resmed's Quality Management System procedures
• Provide input on product regulatory strategy and be involved in communication with regulators and notified bodies

Let's talk about qualification and experience:

• 2+ years of experience navigating technical products through audits like MDR, SOC2, MDSAP, HDS, or any other regulatory framework.  
• Proficiency in report writing, analysis, and compliance procedures.
• Thorough understanding of regulatory frameworks.
• Solid technical knowledge and understanding of product/process design.
• An understanding of Software Development Lifecycle 

Nice to Have:

• B.S or M.S degree.
• At least 4 years of working in a regulatory environment in the healthcare industry

Let's talk about what you can expect:

• A supportive environment that focuses on people development and best practices.
• Opportunity to design, influence, and be innovative.
• Work with global teams and share new ideas.
• Be supported both inside and outside of the work environment.
• The opportunity to build something meaningful and seeing a direct impact on people's lives

With a 30 year history of innovation as a global leader in health technology, we know those good ideas can come from anywhere at ResMed. Innovation and imagination aren't just something we aspire to; they are integral to the way we work. We work hard to provide the opportunity for every employee to do amazing things every day as we shape the future together. Come play!

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Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.