Engineering Compliance and CSV Manager

About the role

Engineering Compliance and Process Validation Lead

AMBOSS seeks a specialized professional to define and enforce compliance for our medical device software. This role combines rigorous validation oversight with engineering leadership to ensure our products meet regulatory standards while maintaining development velocity. You will serve as the critical link between regulatory requirements and engineering execution.

The position exists at the intersection of quality management systems and software development. You will establish the framework that ensures our clinical learning tools remain audit-ready at all stages. Your work directly enables our mission of supporting healthcare professionals through reliable digital tools.

What you'll do

You will own the complete validation lifecycle for our medical device software products. This includes creating and maintaining procedures, templates, and work instructions that satisfy MDR requirements and quality management system standards. Your documentation will serve as the definitive reference for compliant validation approaches across the product portfolio.

Risk-based scoping will guide your validation strategy. You will classify systems by criticality and determine appropriate validation depth for each. All validation activities will produce documented evidence demonstrating reliable and intended performance.

The management of verification and testing activities falls within this role's scope. You will oversee test management practices, defect tracking mechanisms, and build/release tooling. Special attention will go to pipeline steps and automated processes where inspection alone cannot provide sufficient verification.

You will maintain definitive records of validation outcomes. Presenting evidence to regulatory authorities and internal auditors will be a regular responsibility. You will manage deviation records and drive corrective and preventive action plans to closure.

Compliance implementation during day-to-day engineering work defines the Engineering Compliance aspect of this position. You will ensure software lifecycle activities adhere to established standards from initial requirements through final release. This includes design implementation, verification activities, and release documentation.

You will establish compliance requirements within delivery pipelines. Gates, traceability markers, and automated checks will enforce regulatory adherence. Every release will require your validation before deployment to production environments.

Technical documentation quality represents another key area. You will verify that engineering deliverables satisfy both regulatory expectations and internal quality standards. This review happens before any public distribution or external submission.

Requirements

Deep understanding of medical device regulations is essential. Familiarity with pharmacology, biotechnology, or in vitro diagnostics environments provides additional context. Computer system validation experience, including risk assessment approaches, is highly valuable.

Current knowledge of MDR requirements and quality management systems is mandatory. You must understand how these standards apply to software development and clinical decision support tools. IEC standards for medical software development form part of your required expertise.

Technical evaluation capabilities will assess our application portfolio. Reviewing implementation approaches, test strategies, and deployment pipelines requires comfort with modern software practices. Your technical background enables meaningful dialogue with engineering teams.

Audit preparation and evidence presentation represent core skills. You have experience explaining validation logic and technical reasoning to regulatory reviewers. Your documentation withstands scrutiny from notified bodies and inspection authorities.

Change management within regulated contexts is part of the role. You will evaluate design modifications considering regulatory impact. Your assessments determine whether changes require additional validation or documentation updates.

Clear communication in English is required for all interactions. You translate complex regulatory concepts into actionable guidance for diverse audiences. Training sessions help software teams integrate compliance into their workflows.

About the role

This full-time role operates from our Berlin location. The position requires 35 hours of commitment per week. Travel is not part of the job description.

Successful candidates hold eligibility to work in Germany. Your background demonstrates genuine commitment to medical device compliance and patient safety. You view regulations as tools for improving healthcare outcomes rather than administrative obstacles.

The compensation package reflects the specialized nature of this role and expertise requirements.