Compliance Engineer & Product Development

ResMed; Halifax; Hybrid; CAD 70,000 - 90,000; Full time

Job summary

A health technology leader in Halifax is seeking a Compliance Engineer to support product development teams. The role focuses on ensuring software products meet safety and regulatory standards. You will lead design control activities and represent the team in audits. The ideal candidate has experience navigating audits, deep knowledge of regulatory frameworks, and strong report writing skills. This hybrid position offers you the chance to innovate and impact global health technology positively.

Qualifications

• 2+ years of experience navigating technical products through audits like MDR, SOC2, MDSAP, HDS.
• Thorough understanding of regulatory frameworks required.

Responsibilities

• Lead critical design control activities including safety and security risk analysis.
• Represent the team in audits including medical device audits.
• Perform gap analyses to new compliance standards.

Skills

Report writing

Analysis

Compliance procedures

Understanding of regulatory frameworks

Technical knowledge and understanding of product/process design

Understanding of Software Development Lifecycle

Education

B.S or M.S degree

Job description

Overview

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

The role is offered as hybrid.

Let\'s talk about the team and you:

TheCompliance Engineeringteam 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.

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

Qualifications

• 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

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!

#LI-EU

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.