Regulatory & Quality Integration Manager (f/m/x)

Are you looking for more than just a job, for something truly meaningful and rewarding? Then Sysmex Europe SE is the place for you. As the regional headquarters for the EMEA (Europe, Middle East and Africa) region, our company is dedicated to providing essential products that help people worldwide on their healthcare journey.

Your responsibilities

As Regulatory & Quality Integration Manager (f/m/x), you strengthen and connect regulatory and quality capabilities across a diversified product portfolio in a dynamic global regulatory landscape. You ensure effective integration of requirements across the full product lifecycle, enabling compliance, market access and efficient implementation in cross-functional environments.

Your key responsibilities include:

• Driving alignment of regulatory and quality requirements across the full product lifecycle, from development through post-market activities
• Ensuring end-to-end compliance within complex regulatory setups (e.g. manufacturer, importer, EU Authorized Representative)
• Supporting project execution by implementing regulatory and quality requirements in product launches, localization and portfolio initiatives
• Providing regulatory and quality input to lifecycle activities such as design changes, market expansions and product updates
• Ensuring structured, controlled and compliant technical documentation within the quality management system
• Assessing and implementing new and evolving regulatory requirements (e.g. EU AI Act, Cyber Resilience Act, EHDS)
• Identifying regulatory and quality risks or compliance gaps and driving pragmatic, sustainable solutions
• Collaborating with cross-functional stakeholders to ensure consistent and integrated regulatory and quality approaches
• Promoting efficient and harmonized processes across regulatory, quality and product-related activities

Your profile

You are a strong match if you combine solid experience in regulatory affairs and quality management with a pragmatic, solution-oriented mindset and the ability to drive cross-functional collaboration in complex environments.

Ideally, you bring the following qualifications and strengths:

• Degree in Life Sciences, Engineering, Regulatory Affairs or a comparable field
• 5+ years of professional experience in medical devices or IVD, with exposure to Regulatory Affairs and Quality Management
• Proven experience in cross-functional projects (e.g. product launches, localization, remediation or portfolio transitions)
• Solid knowledge of relevant regulations and standards (e.g. ISO 13485, ISO 14971, IVDR) and their application across the product lifecycle within a QMS
• Familiarity with complex regulatory setups (e.g. manufacturer, importer, EU Authorized Representative) and evolving frameworks (e.g. EU AI Act, Cyber Resilience Act, EHDS)
• Strong analytical and problem-solving skills with a structured, proactive and solution-oriented working style
• Excellent stakeholder management and communication skills in international environments
• 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 environment with 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.

Reference: #011531