Senior Medical Device Compliance Specialist

13 hours ago

Kurnool, Andhra Pradesh, India beBeeBiomedical Full time ₹ 15,00,000 - ₹ 20,00,000
Electronic Quality Management Specialist

Orcanos is a global provider of electronic quality management system and application lifecycle management solutions, helping medical device, pharma, and healthcare companies meet compliance standards.

We provide a platform for clients to streamline compliance, risk management, documentation, training, and audits within a single collaborative environment. As an Electronic Quality Management Specialist, you will play a key role in deploying our electronic quality management system and providing clinical application support to our clients.

Responsibilities:

  • Collaborate with medical device and healthcare companies to deploy electronic quality management system and ensure seamless integration with existing systems.
  • Conduct training sessions, workshops, and onboarding programs for healthcare professionals and client teams to enhance their understanding of the system and its applications.
  • Act as a subject matter expert in compliance standards, including ISO 13485, FDA 21 CFR Part 11, GxP, and MDR, to ensure our clients meet regulatory requirements.
  • Provide clinical application support and liaise with hospitals, laboratories, and device manufacturers to resolve any issues that may arise.
  • Gather customer feedback and work closely with product engineering teams to support feature improvements and enhancements to the system.
  • Support clients during audits, inspections, and compliance reviews, ensuring they are fully prepared and compliant with regulatory requirements.

Requirements:

  • Bachelor's or Master's degree in Biomedical Engineering, Clinical Engineering, Biotechnology, or equivalent, with prior experience in medical devices, hospital equipment, or clinical applications.
  • Knowledge of compliance frameworks: ISO 13485, FDA 21 CFR Part 11, GxP, MDR (preferred), with ability to train, mentor, and support healthcare professionals with clarity and confidence.
  • Strong problem-solving mindset and ability to work with cross-functional teams, with excellent communication and presentation skills.

What We Offer:

A dynamic and supportive work environment, with opportunities for professional growth and development, and a competitive compensation package that reflects your value to our team.

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