
Medical Device Regulatory Affairs Expert
6 days ago
Job Title: Regulatory Affairs Specialist
About the Role:
This is a unique opportunity for an experienced regulatory professional to contribute to our mission by ensuring continued product compliance across global markets.
Main Responsibilities:
Represent Regulatory Affairs on cross-functional teams to support post-market compliance efforts
Develop and implement post-market regulatory assessments, including FDA, TGA, and EU Notified Bodies
Support medical device reporting and post-market surveillance activities
Stay up-to-date with global regulatory standards, including FDA, EU MDR, ISO, and IEC
Collaborate with stakeholders to ensure business continuity and compliance
Your Background:
A degree in Engineering, Science, or a related field
6+ years of experience in medical device regulatory affairs
Hands-on experience with post-market regulatory activities
Strong documentation, organizational, and communication skills
Familiarity with EU MDR post-market surveillance and ISO 13485 is a plus
The ideal candidate will have experience working across multiple global markets, excellent adaptability, and prioritization skills.
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