Cybersecurity Specialist
6 days ago
Pramana is seeking a highly skilled Cybersecurity Specialist to ensure the highest standards of cybersecurity in our digital pathology solutions. This critical role requires a deep understanding of medical device cybersecurity, regulatory compliance, and quality management systems.
About the RoleThe ideal candidate will have experience with FDA cybersecurity guidelines, EU MDR requirements, and US Federal Government cybersecurity standards. Key responsibilities include:
- Ensuring compliance with FDA cybersecurity guidelines for medical devices, including risk management and mitigation strategies.
- Preparing and maintaining technical documentation required for CE marking under the EU MDR.
- Collaborating with regulatory affairs to demonstrate substantial equivalence to legally marketed devices, facilitating market clearance.
Qualifications
- 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.
- Experience with ISO 27001 and integrating cybersecurity into QMS.
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