Engineering Compliance and CSV Manager

Meyandy LLC; Berlin; Vor Ort; EUR 110.000 - 140.000; Vollzeit

Zusammenfassung

AMBOSS is seeking an Engineering Compliance Manager and CSV/Process Validation Manager for its medical device software team in Berlin. The role ensures product development is built, verified, and documented to be compliant, trustworthy, and audit-ready, collaborating closely with engineering to set and meet MDR, ISO 13485, IEC 62304, and IEC 82304-1 standards.

You will own the validation processes, manage evidence for audits, handle deviations and CAPAs, and guide engineers on regulatory

Qualifikationen

• Knowledge of medical devices or a regulated industry (pharma, biotech, IVD).
• Experience in computer system validation and/or process validation.

Aufgaben

• Own CSV and process validation for the AMBOSS medical device portfolio; maintain validation state and documentation.
• Represent validation evidence to auditors/regulators and drive CAPAs to resolution.
• As Engineering Compliance Manager, ensure software lifecycle compliance to IEC 62304 and IEC 82304-1.
• Onboard/train engineers on compliance requirements and interact with Notified Bodies.

Kenntnisse

Regulatory knowledge

MDR/ISO13485 familiarity

IEC 62304/IEC 82304-1 understanding

Audits & CAPA handling

Jobbeschreibung

Hi! We are AMBOSS, and we're looking for someone to take the role of Engineering Compliance Manager and CSV & Process Validation Manager in our medical device team.

About AMBOSS

AMBOSS 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, “AMBOSS makes practicing medicine easier and enjoyable. I love what I do, and a big part is because of AMBOSS.”

Why can this position be exciting for you?

At AMBOSS, 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.

You will:

• 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 AMBOSS 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.

You bring:

• Knowledge of medical devices or another regulated industry (pharma, biotech, IVD).
• Experience in, or eagerness to learn, computer system validation and/or process v…

Engineering Compliance and CSV Manager — AMBOSS, Berlin.