Engineering Compliance and CSV Manager

2 нед. назад

GermanyEuropeHybrid

process validationcompliance managementdocumentation

Manage engineering compliance and CSV/process validation in medical device software to ensure regulatory standards and audit readiness.

Требования

Knowledge of medical devices or another regulated industry (pharma, biotech, IVD). Experience in, or eagerness to learn, computer system validation and/or process validation, including risk-based scoping of validation effort, is a plus.
Working knowledge of MDR, ISO 13485, IEC 62304 and IEC 82304-1 as they apply to software.
Familiarity with software engineering, and enough depth in our stack (React, Python, PHP, Go; AWS, Terraform, Kubernetes, ArgoCD) to review pipelines, tests and release processes with engineers as a peer.
Experience representing validation documentation and rationale to auditors and inspectors.
Experience assessing the engineering/technical impact of Design Changes within a regulated development process.
Excellent written and spoken English

Условия

AMBOSSians tell us that innovative work keeps them energized, and employee benefits help them to feel appreciated and empowered. We invest in every AMBOSSian with our employee benefits package, crafted to support financial, physical, and mental health and work-life harmony.
Check out all of our employee benefits here:
We believe that diversity is a powerful driver of innovation and progress. That's why we are committed to fostering an inclusive, respectful, and supportive environment where everyone — regardless of gender, age, ethnic or cultural background, religion, disability, sexual orientation, gender identity — is valued and given equal opportunity to thrive. We warmly welcome people of all backgrounds to help us fulfill our mission: empowering all medical professionals to provide the best possible care.
Even if you don't meet every single point in the job description, we still encourage you to apply. We'd love to hear from you!

Другое

Hi! We are , and we're looking for someone to take the role of Engineering Compliance Manager and CSV & Process Validation Manager in our medical device team.
is a dynamic learning and clinical decision support tool committed to empowering physicians globally to deliver optimal care. Since our inception in 2012, we've harnessed cutting-edge technology to transform the way physicians acquire and apply scientific knowledge. Each AMBOSSian is passionate about being the champion of clinicians today - this motivates and unites us each day towards success. And what does success look like? When a clinician or med student tells us, “ makes practicing medicine easier and enjoyable. I love what I do, and a big part is because of .”
At , we build tools that help doctors and students make critical decisions impacting the healthcare of billions of people worldwide. This position makes sure that our product is built, verified, and documented in a way that's compliant, trustworthy, and audit-ready. You'll work closely with engineering as an independent evaluator, setting the standard for what "done and compliant" means across our medical device software. Join a small, high-impact team ensuring our medical device software meets the regulatory standards needed to safely support healthcare professionals.
As CSV & Process Validation Manager, prove our systems and processes work and produce reliable evidence.
Own the computer system validation and process validation processes for the medical device portfolio — procedures, templates and work instructions — keeping them aligned with MDR and ISO 13485 and updated based on audit findings and team feedback.
Maintain the inventory of systems in scope and decide, risk-based, which need validation and to what depth; plan, execute and document that validation and keep systems in a validated state as they change.
Concentrate validation effort where the evidence is produced — test management, defect tracking, build/release tooling and automated pipeline steps whose output can't be fully verified by inspection alone — confirming these systems and processes reliably produce trustworthy, intended results.
Own the resulting evidence and represent it directly to auditors and regulators; raise, document and own validation deviations and the associated CAPAs through to resolution.
As Engineering Compliance Manager, ensure the medical device product itself is built compliantly, from a day-to-day engineering work perspective
Own compliant execution of the software lifecycle — requirements, design, implementation, verification, release — against IEC 62304 and IEC 82304-1
Define the compliance requirements and gates in our delivery pipeline against IEC 62304 and IEC 82304-1 (traceability tagging, release criteria, automated checks) and partner with engineering to implement them.
Operate the compliance gate in the release flow, keeping the trace intact from user requirement through verification to released evidence. Sign off each release as a required gate; no release ships without your approval.
Ensure engineering-related Technical Documentation deliverables are compliant with regulatory and QMS requirements
Onboard and train software engineers on compliance requirements and how to work within them day-to-day.
Act as the point of contact for audits and technical reviews on engineering-related topics, representing the team's compliance posture to auditors and Notified Body reviewers.
Drive resolution of audit findings and deficiencies affecting engineering.
Assess the engineering impact of Design Changes before they are implemented.
Identify and drive adoption of tooling the team is missing to work compliantly — both inside the QMS and on the engineering side.
Working closely with engineers, Quality Assurance and Regulatory Affairs — able to challenge and be challenged on technical detail.
Strong communication and training skills, with the ability to explain complex validation requirements to cross-functional stakeholders
Structured, detail-oriented way of working, with the ability to balance regulatory rigor with practical, workable processes for development teams