Regulatory Compliance Expert
5 days ago
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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