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
Employment type
Job function
Industries
- Medical Equipment Manufacturing
- Pharmaceutical Manufacturing
- Biotechnology Research