2072 IT & Software Developer jobs in Germany
Regulatory & Quality Compliance Manager (f/m/x)
47.000 - 87.000 €
Sysmex Europe SE
Bei der Neuen Münze 19, Hamburg
47.000 - 87.000 €
Requirements
Must:
- Degree in Computer Science, Engineering, Life Sciences or a comparable field
- 5+ years of experience in regulated software development, software QA and quality management system
- Strong knowledge of medical device software regulations and standards (e.g. ISO 13485, IEC 62304, IVDR)
- Solid understanding of agile software development in regulated environments, including frameworks such as TIR 45
- Hands-on experience in audit support, CAPA management and compliance governance
- Experience with software post-market surveillance, vigilance or complaint handling is considered a plus
- Structured, independent and detail-oriented working style with strong analytical skills
- Confident communication skills and ability to advise and challenge stakeholders in a constructive manner
- Fluent in English; German language skills are a plus
Responsibilities
- Ensuring compliance with applicable medical device software regulations and standards, including ISO 13485, ISO 14971, IEC 62304, IEC 62366 and IVDR
- Defining, maintaining, and governing software-related quality policies, procedures, SOPs, templates and lifecycle frameworks
- Acting as governance authority for software verification, validation and traceability across agile and hybrid development models
- Translating regulatory and normative changes into actionable quality and compliance requirements
- Driving CAPA processes and ensuring sustainable resolution of audit findings and compliance gaps
- Leading and facilitating internal and external audits and inspections, including preparation, execution and follow-up activities
- Supporting and guiding cross-functional stakeholders (e.g. Engineering, Product Management) on compliance-related topics
- Overseeing software-related post-market surveillance activities in alignment with regulatory requirements
- Acting as escalation point for regulatory, compliance and release-related risks and decisions
Description
At Sysmex Europe SE, we are dedicated to providing essential products that help people worldwide on their healthcare journey. We offer an appreciative work environment, open corporate culture, flat hierarchies, and an inclusive atmosphere. Our flexible work model allows 60% mobile working and 40% on-site with 30 days of annual leave. We provide an attractive compensation package, health and wellbeing initiatives, and various opportunities for social responsibility. Join us in our EMEA Campus and contribute to our innovative team.
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You can find IT Manager salaries in Germany here.
How many IT Manager jobs are in Germany?
Currently, there are 2072 Manager openings. Check also: CTO jobs, ERP jobs, Architect jobs - all with salary brackets.
Is Germany a good place for IT Managers?
Germany is one of the best countries to work as a IT Manager. It has a vibrant startup community, growing tech hubs and, most important: lots of interesting jobs for people who work in tech.
Which companies are hiring for IT Manager jobs in Germany?
Quadriga Media Berlin GmbH, Spot On You Consulting, 7Assets GmbH, HEDELIUS Maschinenfabrik GmbH, Vertec AG, Impulse Medien GmbH, EHI-Verwaltungsges. mbH among others, are currently hiring for Manager roles in Germany.
The company with most openings is adesso SE as they are hiring for 129 different IT Manager jobs in Germany. They are probably quite committed to find good IT Managers.
The company with most openings is adesso SE as they are hiring for 129 different IT Manager jobs in Germany. They are probably quite committed to find good IT Managers.