Medical Device Regulatory Affairs Specialist
2 days ago
We're seeking a Post-Market Consultant to join our Regulatory Affairs team.
You will collaborate with stakeholders across Quality, Product Development, and Global Product Management to maintain compliance for marketed medical devices.
Key Responsibilities- 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
- 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
Familiarity with EU MDR post-market surveillance and ISO 13485 is a plus.
About UsWe focus on creating innovative health solutions that improve lives. We strive for diversity and inclusivity, encouraging individual expression and innovation in the workplace.
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