Your responsibilities
As Regulatory & Quality Compliance Manager - Software (f/m/x), you act as the independent governance authority for regulatory compliance, quality systems and software lifecycle conformity across Sysmex’ regulated software portfolio. You ensure audit readiness, regulatory compliance, and continuous post-market oversight within the EMEA MedTech environment, while enabling compliant and efficient software development and release processes.
Your key responsibilities include:
- 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
Your profile
You are a strong match if you combine solid expertise in regulated software environments with a structured, governance-oriented mindset and the ability to collaborate effectively across functions. Ideally, you bring the following qualifications and strengths:
- 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
Our benefits
We are an aspiring corporate group where respect and trust form the basis for cooperation and communication within Sysmex.
- Culture & cooperation An appreciative work environment, open corporate culture, flat hierarchies and an inclusive and caring atmosphere. Working in an innovative and international environmentwith a broad learning and development landscape in our EMEA Campus, after-work events for internal networking
- Work-life balance Flexible working through flextime and a hybrid working model (60% mobile working, 40% on-site), 30 days annual leave
- Additional benefits Attractive compensation package including Christmas and vacation pay, childcare allowance, capital-forming benefits, subsidy for company pension scheme, corporate benefits, relocation assistance, subsidised lunch in our canteen
- Health & wellbeing Subsidized EGYM Wellpass with access to 13,500 studios, plus in-house gym, various sports courses, massages, company medical and psychological care, workplace glasses, and general health management
- Mobility Subsidy for the public transport “Deutschlandticket”, free parking, bike leasing via JobRad
- Social Responsibility Various opportunities to get involved in different sustainability and charity initiatives, climate friendly and respectful use of resources
Did we spark your interest? Then we look forward to receiving your application with salary requirements and the earliest possible starting date.
