Cybersecurity Technical Writer (CONTRACT)

Technical Writer

Contract

$35-40/hour

We are seeking a skilled Cybersecurity Technical Writer to join the MedTech cybersecurity team on a contract basis for a duration of 3-4 months. The ideal candidate will possess expertise in cybersecurity with a focus on medical devices, capable of authoring and updating documentation that adheres to FDA Pre-Market guidance.

Responsibilities:

Develop and maintain the Product Security Plan, outlining strategies and measures to safeguard medical device cybersecurity.

Create a comprehensive Threat Model detailing potential cyber threats and vulnerabilities.

Conduct Product Security Risk Assessments to identify and mitigate cybersecurity risks.

Define Design Input Security Requirements to ensure secure product development.

Compile a Software Bill of Material (SBOM) to document software components and dependencies.

Produce a Cybersecurity Architecture Document with various perspectives to articulate the system's security architecture.

Complete the Medical Device Security Information Sheet (MDS2) as per regulatory requirements.

Draft a Cybersecurity Whitepaper elucidating key cybersecurity principles and practices.

Generate Product Security Reports summarizing cybersecurity measures and findings.

Requirements:

Expertise in Cybersecurity: Demonstrated proficiency in cybersecurity principles, particularly in the context of medical devices. Understanding of common cybersecurity threats, vulnerabilities, and risk mitigation strategies is essential.

Familiarity with FDA Pre-Market Guidance: Thorough knowledge of FDA regulations and guidelines pertaining to medical device cybersecurity, including the FDA Pre-Market Cybersecurity Guidance. Ability to ensure compliance with regulatory requirements in all documentation.

Technical Writing Skills: Exceptional technical writing skills with the ability to articulate complex cybersecurity concepts clearly and concisely. Strong attention to detail and grammar, with proficiency in creating well-structured and organized documentation.

Documentation Development: Experience in developing a wide range of cybersecurity documentation, including Product Security Plans, Threat Models, Risk Assessments, Design Input Security Requirements, Software Bill of Materials (SBOM), Cybersecurity Architecture Documents, MDS2 forms, Whitepapers, and Product Security Reports.

Cybersecurity Knowledge Transfer: Ability to effectively communicate cybersecurity concepts to various stakeholders, including engineers, developers, project managers, and regulatory compliance teams. Facilitate knowledge transfer sessions and ensure understanding of cybersecurity requirements across the organization.

Attention to Regulatory Compliance: Ensure all cybersecurity documentation meets relevant regulatory standards and guidelines, including FDA, ISO, and other applicable regulations. Conduct thorough reviews and validations to address any compliance gaps.

Deadline Management: Proven track record of managing multiple documentation projects simultaneously within tight deadlines. Ability to prioritize tasks effectively and deliver high-quality documentation on schedule.