Regulatory Compliance Expert

5 days ago


Bengaluru, Karnataka, India Pramana Full time

About This Role :

We are seeking a highly skilled Cybersecurity Professional to join our team and contribute to the development of our autonomous systems for pathology labs. The ideal candidate will have a deep understanding of medical device cybersecurity, regulatory compliance, and quality management systems.

Key Responsibilities :

  • Ensure compliance with FDA cybersecurity guidelines for medical devices, including risk management and mitigation strategies.
  • Prepare and maintain technical documentation required for CE marking under the EU MDR.
  • Collaborate with regulatory affairs to demonstrate substantial equivalence to legally marketed devices, facilitating market clearance.
  • Conduct comprehensive risk assessments to identify potential cybersecurity threats and vulnerabilities.
  • Develop and implement risk mitigation strategies to protect our digital pathology systems.

Requirements :

  • Bachelor's degree in Computer Science, Information Security, or a related field; advanced degree preferred.
  • Minimum of 4 years of experience in cybersecurity, preferably in the medical device or healthcare industry.
  • In-depth knowledge of FDA cybersecurity guidelines, EU MDR requirements, and US Federal Government cybersecurity standards.

Estimated Salary : $125,000 - $155,000 per year



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