Biomedical Engineer – Compliance Specialist

2 days ago

Gandhinagar, Gujarat, India beBeeCompliance Full time ₹ 10,00,000 - ₹ 16,00,000

About the Role:

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

Key Responsibilities:

  • Collaborate with medical device and healthcare companies to deploy Orcanos eQMS.
  • Conduct training sessions, workshops, and onboarding programs for healthcare professionals and client teams.
  • 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 to support feature improvements.
  • Support clients during audits, inspections, and compliance reviews.

Requirements:

  • 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 (to engage medical professionals and regulatory staff).

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.

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