Security Architect

Overview

We are seeking an experienced Software/Security Architect to support a short-term project focused on the cyber security aspects of a 510(k) 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

Details

• Location: remote/flexible (occasional meetings possible)


• Start: as soon as possible

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Information Technology

Industries

• Medical Equipment Manufacturing


• Pharmaceutical Manufacturing


• Biotechnology Research