Krtya Technologies Pvt Ltd
Website:
krtya.com
Job details:
About Orcanos
Orcanos is a global provider of eQMS (Electronic Quality Management System) and ALM (Application Lifecycle Management) solutions, helping medical device, pharma, and healthcare companies meet ISO 13485, ISO 14971, FDA 21 CFR Part 11, and other compliance standards.
Our platform enables clients to streamline compliance, risk management, documentation, training, and audits—all within a single collaborative environment.
Job Location: Surat, India
Experience: 2-7 Years
What You’ll Do
- Collaborate with medical device and healthcare companies to deploy and implement the Orcanos eQMS platform.
- Conduct training sessions, workshops, and onboarding programs for healthcare professionals and client teams.
- Act as a subject matter expert in compliance standards, including ISO 13485 and FDA 21 CFR Part 11.
- Provide clinical application support and liaise with hospitals, laboratories, and medical device manufacturers.
- Gather customer feedback and work closely with Product and Engineering teams to support feature enhancements and process improvements.
- Support clients during audits, inspections, and compliance reviews.
What You’ll Bring
- Education: Bachelor’s or Master’s degree in Biomedical Engineering, Clinical Engineering, Biotechnology, or an equivalent discipline.
- Experience: Prior exposure to medical devices, hospital equipment, clinical applications, or regulated healthcare environments.
- Hands-on experience in implementing or supporting enterprise software solutions such as CRM, ERP, PLM (Product Lifecycle Management), or PDM (Product Data Management) systems.
- Knowledge of compliance frameworks: ISO 13485, FDA 21 CFR Part 11, GxP, and MDR (preferred).
- Ability to train, mentor, and support healthcare professionals with clarity and confidence.
- Strong problem-solving mindset and ability to collaborate with cross-functional teams.
- Excellent communication and presentation skills to engage medical professionals, quality teams, and regulatory stakeholders.
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.
- Strong project management and customer-facing implementation skills.
Language Requirements
- Fluency in English (written and spoken) is mandatory.
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