AI, Digital, and Cyber Compliance

Job Description

Ketryx is seeking an experienced AI, Digital, and Cyber Compliance contractor. The role involves acting as an internal consultant to clients and the Client Operations team, promoting a deep understanding of medical device cybersecurity. The ideal candidate should possess an analytical mindset, thrive in interactions with others, and have experience in the medical device industry or with the FDA. They should also be capable of delivering results in a fast-paced environment, possess excellent organizational skills, and have a background in computer science and/or engineering.

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

Requirements:

• 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.

What Ketryx Offers:

• Competitive compensation
• Generous stock options possible
• Opportunity to learn and grow as part of a global team
• Hybrid work model (mix of work from home and office is possible)
• Generous PTO for full-time