
Medical Device Compliance Specialist
13 hours ago
Orcanos is a global provider of Electronic Quality Management System (eQMS) and Application Lifecycle Management solutions. We help medical device, pharma, and healthcare companies meet regulatory compliance standards such as ISO 13485 and FDA 21 CFR Part 11.
Our platform enables clients to streamline compliance, risk management, documentation, training, and audits all within a single collaborative environment.
Key responsibilities include collaborating with medical device and healthcare companies to deploy eQMS, conducting training sessions, workshops, and onboarding programs for healthcare professionals and client teams.
You will act as a subject matter expert in compliance standards and provide clinical application support and liaison services with hospitals, laboratories, and device manufacturers.
Additionally, you will gather customer feedback and work closely with product & engineering teams to support feature improvements.
Support clients during audits, inspections, and compliance reviews.
Required Skills and Qualifications- Education: Bachelor's or Master's degree in Biomedical Engineering, Clinical Engineering, Biotechnology, or equivalent.
- Experience: 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.
- Strong problem-solving mindset and ability to work with cross-functional teams.
- Excellent communication & presentation skills.
- Opportunity to work with a global provider of eQMS and ALM solutions.
- Chance to collaborate with medical device and healthcare companies worldwide.
- Collaborative work environment with diverse stakeholders.
- Fluency in English (written & spoken) is mandatory.
- Adaptability to handle regulatory challenges and evolving customer needs.
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