The Washington D.C. office of Hogan Lovells Cadwalader is seeking a skilled Software Engineer to own and support the software and cybersecurity documentation that accompanies FDA regulatory submissions for our software and Software as a Medical Device (SaMD) products. This role is a hands-on technical position focused on writing, reviewing, and maintaining the software-specific sections of FDA submissions, supporting cybersecurity documentation, answering technical questions from cross-functional teams, and contributing to Quality Management System (QMS) activities. The ideal candidate is a software engineer with direct experience working in a regulated healthcare or life sciences environment who understands FDA expectations for software documentation.
Key ResponsibilitiesSoftware Sections for FDA Submissions- Author, review, and maintain the software description and software documentation sections of FDA regulatory submissions, including 510(k), PMA supplement, and De Novo filings
- Develop and update software-related submission content such as software level of concern analyses, software requirements specifications (SRS), architecture and design descriptions, traceability matrices, and verification and validation summaries
- Review and prepare the cybersecurity sections of submissions, including threat modeling documentation, cybersecurity risk assessments, Software Bill of Materials (SBOM), and vulnerability/patch management plans in accordance with FDA premarket cybersecurity guidance
- Serve as the technical subject matter expert (SME) for software-related questions from regulatory affairs, quality, and clinical teams during the submission preparation process
- Respond to FDA Additional Information (AI) requests and deficiency questions related to software and cybersecurity content
- Stay current with FDA guidance documents on software, SaMD, cybersecurity, and AI/ML-enabled devices to ensure submission content reflects the latest expectations
Quality System Support- Support Quality Management System (QMS) activities related to software development, including design controls, software development lifecycle (SDLC) documentation, and design history file (DHF) maintenance
- Contribute to the development and maintenance of software-related standard operating procedures (SOPs), work instructions, and templates within the QMS
- Participate in internal audits and inspection readiness activities as the software engineering representative, helping prepare and organize software SDLC records, test documentation, and CAPA evidence
- Assist with software-related corrective and preventive actions (CAPAs), non-conformance investigations, and root cause analyses
- Support complaint handling and post-market activities that require software engineering input or analysis
General- Maintain working knowledge of applicable regulations, standards, and guidance documents relevant to medical device software, including 21 CFR Part 820, IEC 62304, IEC 62443, ISO 14971, and FDA guidance on SaMD, cybersecurity, and computer software assurance
- Act as a go-to technical resource for internal teams, answering questions about software architecture, design decisions, testing strategies, and cybersecurity controls as they relate to regulatory requirements
- Support cross-functional teams in translating regulatory requirements into actionable engineering tasks within agile and iterative development workflows
Qualifications- Bachelor's degree in software engineering, computer science, computer engineering, biomedical engineering, or a related technical field; advanced degree a plus
- 3-7 years of experience as a software engineer or software quality engineer in a regulated healthcare, life sciences, or medical device environment
- Hands-on experience writing or reviewing the software and cybersecurity sections of FDA premarket submissions (510(k), De Novo, PMA supplements)
- Solid understanding of the software development lifecycle (SDLC) for medical devices, including IEC 62304 lifecycle processes, risk management per ISO 14971, and design control requirements under 21 CFR Part 820
- Demonstrated experience with cybersecurity documentation for FDA submissions, including threat modeling, SBOM preparation, and vulnerability management
- Experience supporting Quality Management System (QMS) activities, including design controls, DHF documentation, CAPAs, and internal audits
- Strong technical writing skills with the ability to produce clear, accurate, and regulator-ready software documentation
- Ability to serve as a technical resource, fielding questions from regulatory, quality, and clinical stakeholders on software and cybersecurity topics
- Proficiency in modern software development practices (e.g., version control, CI/CD, agile methodologies) within a regulated environment
Preferred Qualifications- Experience with cloud-hosted, AI/ML-enabled, or continuously learning software in a regulated medical device environment
- Familiarity with FDA's Digital Health Center of Excellence (DHCoE) policies and Computer Software Assurance (CSA) guidance
- Experience with EU MDR/IVDR technical documentation for software products
- Knowledge of cybersecurity frameworks applicable to medical devices (e.g., IEC 62443, NIST Cybersecurity Framework)
- Familiarity with software composition analysis (SCA) tools, static/dynamic analysis tools, and penetration testing
- Certified Software Quality Engineer (CSQE) or similar quality/engineering certification
Salary is commensurate with experience. This position is eligible for additional forms of compensation, which may include annual performance bonuses and discretionary bonuses. Employees in this role are also eligible for benefits offered by the firm, subject to applicable plan terms and conditions, which currently include medical, dental, and vision insurance; a 401(k) retirement plan; and paid time off. Additional benefits may include relocation. Please review this link for more information regarding employee benefits in the United States.
A resume or CV is a must for our application system. We also encourage you to include a cover letter to tell us why you are interested in this position.
To apply please complete the on-line application, attaching a resume and transcript.
This job description sets forth the responsibilities of this position and may be changed from time to time as shall be determined.
