1 день назад
Engineering Compliance and CSV Manager (Medical Devices)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Engineering Compliance and CSV Manager (Medical Devices): Ensuring medical device software and its development processes are compliant, validated, documented, and audit-ready with an accent on computer system validation, process validation, and regulated software lifecycle controls. Focus on designing compliance gates, maintaining traceability, evaluating technical changes, and producing reliable evidence for auditors and regulators.
Location: Berlin or remote within Germany
Company
A medical technology and clinical decision support company developing digital tools that help physicians and medical students make informed healthcare decisions.
What you will do
- Own computer system validation and process validation procedures, templates, work instructions, inventories, and risk-based validation plans.
- Plan, execute, document, and maintain validation for systems supporting testing, defect tracking, builds, releases, and automated pipelines.
- Define and operate engineering compliance gates across requirements, design, implementation, verification, and release.
- Maintain traceability from user requirements through verification and released evidence, and approve releases as a required compliance gate.
- Ensure technical documentation meets regulatory and quality management system requirements.
- Represent engineering compliance and validation evidence in audits, technical reviews, and interactions with regulators and Notified Bodies.
Requirements
- Knowledge of medical devices or another regulated industry such as pharma, biotech, or IVD.
- Working knowledge of MDR, ISO 13485, IEC 62304, and IEC 82304-1 as applied to software.
- Familiarity with software engineering and sufficient technical depth to review pipelines, tests, and release processes with engineers.
- Experience presenting validation documentation and rationale to auditors or inspectors.
- Experience assessing the engineering and technical impact of design changes in a regulated development process.
- Excellent written and spoken English required.
Nice to have
- Experience with computer system validation or process validation, including risk-based scoping.
- Familiarity with React, Python, PHP, Go, AWS, Terraform, Kubernetes, and ArgoCD.
Culture & Benefits
- Close collaboration with engineering, Quality Assurance, and Regulatory Affairs.
- Inclusive, respectful, and supportive work environment.
- Employee benefits supporting financial, physical, and mental health.
- Focus on work-life harmony and practical, workable compliance processes.
- Training and onboarding support for regulated engineering practices.
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