Regulatory Affairs

2 weeks ago

Sydney, Australia ResMed Full time

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 _

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