
Medical Device Compliance Specialist
22 hours ago
About Us:
We are a global provider of Electronic Quality Management System and Application Lifecycle Management solutions, helping medical device, pharma, and healthcare companies meet ISO 13485 and FDA compliance standards.
Our platform enables clients to streamline processes, manage risk, document procedures, train staff, and conduct audits within a single collaborative environment.
Main Responsibilities:- Collaborate with medical device and healthcare companies to deploy our Electronic Quality Management System
- Deliver training sessions and workshops for healthcare professionals and client teams
- Serve as an expert in compliance standards (ISO 13485)
- Provide clinical application support and liaise with hospitals and device manufacturers
- Gather customer feedback and work closely with product teams to enhance features
- Bachelor's or Master's degree in Biomedical Engineering or equivalent field
- Prior experience in medical devices or clinical applications
- Knowledge of compliance frameworks: ISO 13485 and FDA Part 11
- Strong problem-solving skills and ability to collaborate with cross-functional teams
Soft Skills:
- Analytical and detail-oriented with strong documentation skills
- Excellent communication and presentation skills
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