We are seeking an experienced Software/Security Architect to support a short-term project focused on the cyber security aspects of a 510k submission in the medical device sector.
Company Description:
An innovative medical technology company based in the Netherlands, known for its collaborative culture and flexible work setup. The organization combines software, hardware, and data science teams to develop next-generation diagnostic solutions.
Responsibilities:
Conduct security assessments and define security controls
Update and document technical security plans, risk management, and verification activities
Ensure cybersecurity requirements are clearly captured and compliant with relevant standards
Support regulatory documentation, ideally including FDA 510(k) submissions for a Class IIa medical device.
Requirements:
Strong background in software/security architecture
Proven experience in security documentation for regulated industries (medical devices a plus)
Familiarity with FDA 510(k) cybersecurity documentation is highly desirable
Ability to identify and close gaps in existing technical files