
Medical Device Specialist
12 hours ago
Orcanos is a leading provider of eQMS and ALM solutions for medical device, pharma, and healthcare companies. Our platform enables clients to streamline compliance, risk management, documentation, training, and audits.
Job Overview:
We are seeking a Medical Device Specialist to collaborate with our clients and deploy Orcanos eQMS. The ideal candidate will have experience in medical devices, hospital equipment, or clinical applications, and possess strong problem-solving skills.
Key Responsibilities:
- Collaborate with clients to deploy Orcanos eQMS
- Conduct training sessions and workshops for healthcare professionals
- Act as a subject matter expert in compliance standards (ISO 13485, FDA 21 CFR Part 11)
- Provide clinical application support and liaise with hospitals, laboratories, and device manufacturers
- Gather customer feedback and work closely with product & engineering teams
Required Skills:
- 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
Soft Skills:
- Analytical and detail-oriented with strong documentation skills
- Empathy and patience while supporting clinical staff and clients
- Collaborative mindset to work with diverse stakeholders
- Adaptability to handle regulatory challenges and evolving customer needs
Language Requirements:
- Fluency in English (written & spoken) is mandatory
What We Offer:
- A dynamic and collaborative work environment
- The opportunity to work with cutting-edge technology
- Continuous learning and development opportunities
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