Regulatory Affairs – Post-Market Consultant

Sydney, NSW
Permanent
Part-time

2 months ago

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 RoleAs 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 DoingRepresent Regulatory Affairs on selected post-market cross-functional teamsPrepare and implement post-market regulatory assessments (e.g., FDA, TGA, EU Notified Bodies)Support medical device reporting (MDR) and post-market surveillance activitiesMonitor updates to global regulatory standards (FDA, EU MDR, ISO, IEC) and ensure alignmentAssist with special projects to support business continuity and complianceWhat You’ll BringA degree in Engineering, Science, or a related field6+ years’ experience in medical device regulatory affairsHands-on experience with post-market regulatory activitiesExcellent documentation, organizational, and stakeholder communication skillsComfortable working independently in a flexible, part-time consultancy modelNice-to-Have:Familiarity with EU MDR post-market surveillance and ISO 13485Experience working across multiple global markets (e.g., US FDA, TGA, EU)Ability to quickly adapt and prioritize tasks in a dynamic environmentEngagement Details
Part-time (3 days/week)6-month contractRemote WorkImmediate start preferredJoining 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!

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