Sr. Quality & Compliance Manager (m/f/d)

Wellster is one of Europe’s leading digital healthcare platforms. We develop digital products and healthcare services that make high-quality medical care more accessible, convenient and patient-centric.

We are looking for a Senior Quality & Compliance Manager to take ownership of our quality, compliance and regulatory framework across our digital products, medical services and operational processes.

In this role, you will establish scalable structures, lead relevant certification and audit processes and work closely with Medical, Product, Technology and Operations. You will ensure that regulatory and quality requirements are embedded into our day-to-day operations and product development without creating unnecessary complexity or slowing down the business.

Your tasks would be...

• Own and continuously develop our company-wide quality, compliance and regulatory framework across digital products, medical services and internal operations

• Lead TÜV certification and recertification projects, including preparation, documentation, internal coordination and communication with external auditors

• Establish, maintain and continuously improve our quality management system, policies, standard operating procedures and control mechanisms

• Ensure compliance with applicable data protection requirements, including the DSGVO, and coordinate closely with internal and external data protection experts

• Translate medical, regulatory and quality requirements into practical processes, responsibilities and controls for Medical, Product, Tech and Operations teams

• Lead internal and external audits, risk assessments, corrective and preventive actions and the follow-up of identified findings

• Support product and service development by assessing compliance risks and ensuring that regulatory, quality and patient-safety requirements are considered from the outset

• Define relevant quality and compliance KPIs, monitor adherence and provide transparent reporting to management and relevant stakeholders

• Build and manage a high-performing quality and compliance function, including team development, prioritization and allocation of responsibilities

• Develop and deliver training, guidance and communication to strengthen quality awareness and a pragmatic compliance culture across the organization

You will fit well, when you …

• Have several years of experience in quality management, compliance, regulatory affairs or a comparable role, ideally within healthcare, digital health, medical services or another regulated industry

• Have practical experience with TÜV certifications, quality-management systems and external audit processes

• Have a strong understanding of the DSGVO and experience translating data-protection requirements into operational processes

• Understand medical compliance, patient-safety considerations and regulatory requirements affecting healthcare products and services

• Have experience establishing and scaling quality and compliance structures in a growing or fast-changing organization

• Can communicate complex regulatory requirements clearly and turn them into pragmatic, proportionate and business-oriented solutions

• Are highly structured, detail-oriented and capable of managing several certification, audit and improvement initiatives simultaneously

• Are comfortable challenging existing processes while remaining collaborative and solution-oriented

• Have professional working proficiency in English and German

Important: Official correspondence regarding job applications will always come from an @wellsterhealth.com email address.