This is a Regulatory Affairs – Post-Market Consultant role with ResMed based in Sydney, NSW, AU ResMed Role Seniority - mid level More about the Regulatory Affairs – Post-Market Consultant role at ResMed At ResMed, we’re passionate about improving lives through innovative and connected health solutions. We’re currently seeking a Regulatory Affairs Consultant to support our Post-Market Compliance efforts on a short-term, part-time basis during a critical period for the team. This is an excellent opportunity for an experienced regulatory professional to contribute meaningfully to ResMed’s mission by ensuring continued product compliance across global markets. About the Role As a Post-Market Consultant in the Regulatory Affairs team, you’ll work across a variety of post-market regulatory activities to help maintain compliance for ResMed’s marketed medical devices. You’ll collaborate with stakeholders across Quality, Product Development, and Global Product Management, providing regulatory input, delivering key assessments, and supporting ongoing product lifecycle activities. What You'll Be Doing Represent Regulatory Affairs on selected post-market cross-functional teams Prepare and implement post-market regulatory assessments (e.g., FDA, TGA, EU Notified Bodies) Support medical device reporting (MDR) and post-market surveillance activities Monitor updates to global regulatory standards (FDA, EU MDR, ISO, IEC) and ensure alignment Assist with special projects to support business continuity and compliance What You’ll Bring A degree in Engineering, Science, or a related field 6 years’ experience in medical device regulatory affairs Hands-on experience with post-market regulatory activities Excellent documentation, organizational, and stakeholder communication skills Comfortable working independently in a flexible, part-time consultancy model Nice-to-Have: Familiarity with EU MDR post-market surveillance and ISO 13485 Experience working across multiple global markets (e.g., US FDA, TGA, EU) Ability to quickly adapt and prioritize tasks in a dynamic environment Engagement Details Part-time (3 days/week) 6-month contract Remote Work Immediate start preferred 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! Before we jump into the responsibilities of the role. No matter what you come in knowing, you’ll be learning new things all the time and the ResMed team will be there to support your growth. Please consider applying even if you don't meet 100% of what’s outlined Key Responsibilities ️ Representing Regulatory Affairs Preparing regulatory assessments Supporting post-market activities Key Strengths Medical device regulatory affairs ️ Documentation and organizational skills Stakeholder collaboration Familiarity with EU MDR Global market experience ⚡ Adaptability Why ResMed is partnering with Hatch on this role. Hatch exists to level the playing field for people as they discover a career that’s right for them. So when you apply you have the chance to show more than just your resume. A Final Note: This is a role with ResMed not with Hatch.
