
Medical Device Compliance Specialist
1 day ago
Orcanos is a global provider of eQMS (Electronic Quality Management System) and ALM (Application Lifecycle Management) solutions. Our platform enables clients to streamline compliance, risk management, documentation, training, and audits—all within a single collaborative environment.
We are seeking an experienced Medical Device Compliance Specialist to collaborate with medical device companies to deploy our eQMS solution. As a key member of our team, you will be responsible for:
- Deploying eQMS solution to medical device companies
- Conducting training sessions and workshops for healthcare professionals and client teams
- Providing clinical application support and liaising with hospitals, laboratories, and device manufacturers
To succeed in this role, you should have a solid understanding of compliance frameworks such as ISO 13485, FDA 21 CFR Part 11, GxP, and MDR. You will also need excellent communication and presentation skills to engage with medical professionals and regulatory staff.
Required Skills and Qualifications- Bachelor's or Master's degree in Biomedical Engineering, Clinical Engineering, Biotechnology, or equivalent
- Prior exposure to medical devices, hospital equipment, or clinical applications
- Knowledge of compliance frameworks: ISO 13485, FDA 21 CFR Part 11, GxP, MDR (preferred)
- Ability to train, mentor, and support healthcare professionals with clarity
- Opportunity to work with a global provider of eQMS and ALM solutions
- Collaborative work environment
- Chance to make a meaningful impact on the medical device industry
Apply now to join our dynamic team and contribute to shaping the future of medical device compliance
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