AI, Digital, and Cyber Compliance

Job Title: AI, Digital, and Cyber Compliance
Employment Status: Contract
Office Hours: flexible
Location: Remote

Ketryx is excited to incorporate an experienced AI, Digital, and Cyber Compliance contractor to our team. This position will act as an internal consultant to our clients and Client Operations team to share and encourage a deep understanding of medical device cybersecurity. If you have an analytical mindset, energized by interactions with others, and have previous experience working in the medical device industry or FDA, this may be the right position for you!

Our ideal candidates will be capable of providing results in a fast-paced and demanding atmosphere. Someone who has excellent organizational skills, eager to work in a fast-growing startup, and a background in computer science and/or engineering will do well in this position. In this role, you will be allowed the opportunity to implement your target-driven work ethic and support Ketryx's mission to impact 100 million patient lives by 2030. This position may be based anywhere in the US or Canada, but we are unable to sponsor or take over sponsorship of an employment Visa at this time.

Responsibilities:

• Act as internal consultant and technical leader for Medical Device Cybersecurity Engagement planning.
• Assist teams to design regulatory strategies for the cybersecurity component of medical device submission pathways.
• Design internal training and process materials for the medical device cybersecurity practice of Ketryx’s overall Quality and Regulatory professional services.
• Conduct risk assessments and vulnerability analyses on traditional medical devices and SaMD components and infrastructure.
• Work with the Ketryx R&D teams to design and implement features to manage medical device cybersecurity workflows.

Required Skills:

• 5 years of working in a cybersecurity role on a team building and shipping medical devices. Beneficial if the device included an AI component
• Previous experience authoring or contributing to the Software/Firmware and Cybersecurity/Interoperability content of a 510(k)/PMA/DeNovo or Cybersecurity report of a CE-marked device.
• Strong working knowledge of TIR57:2016, NIST 800-30, IEC 62304 and Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions- September 26, 2023 (FDA).
• Experience configuring vulnerability monitoring platforms such as Snyk is a plus.
• Previous background in computer science and/or engineering.
• Ability to grasp extremely complex technical concepts quickly.
• Strong written and verbal communication, presentation, and interpersonal skills.
• Ability to convey complex solutions in a clear and compelling manner.
• Strong organizational skills and habits.
• A proactive mindset, eager and open to learn and grow in a fast-paced, startup environment.

Preferred Skills:

• Previous experience in a startup environment strongly preferred.
• Previous experience in Quality Management.
• Previous experience in Software Development.

Keywords: quality, QA, change request, change requirement, V-Model, engineer, feature descriptions, SaaS, customer feedback, computer science, comp sci, Cambridge, MA, startup, software development, Kendall Square, Series A, FDA, AI Security, cybersecurity, IT security, cybersecurity reviewer

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