Quality Assurance & Regulatory Affairs Specialist

Diaverum is a Swedish-born, multinational healthcare organisation that provides life-enhancing renal care to patients with Chronic Kidney Disease (CKD), empowering them to live fulfilling lives.  As a global leader and the largest independent renal service provider in Europe, we care for around 41,000 patients across 450 clinics in 24 countries globally.​

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Our focus is to provide renal care tailored to patients’ needs and choices, offering a portfolio of treatments ranging from preventive care, haemodialysis, peritoneal dialysis and home care, to coordination of patients’ comorbidities and holiday dialysis.​

CKD is a global and escalating challenge today affecting about 10% of the world’s adult population. It’s primarily caused by lifestyle diseases such as diabetes, and its prevalence is increasing, particularly in developing countries and among low income individuals. We ensure that our clinics are a safe and familiar space where all our patients are made to feel welcome.​

Our vision is to transform the industry through patient-centric digital innovations, delivering and broadening access to the highest quality of care.​

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At the centre of what we do is our standardised, proprietary care delivery model, enabled by a continuously evolving digital infrastructure. We strive to ensure superior medical outcomes exceeding those demanded by national healthcare systems and we support patients by improving personalised care, ease of use and new services through technology.​

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Diaverum employs approximately 13,000 people and operates 450 clinics in 24 countries globally. Diaverum has its head office in Malmö, Sweden.

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About the Role

We are seeking a motivated and structured Quality Assurance & Regulatory Affairs (QA/RA) Specialist to join our team as we finalize CE marking and ISO 13485 certification for our d.CARE Platform, a Class II medical device software.

In this role, you will play a key part in maintaining and improving our Quality Management System (QMS) and coordinating the creation and maintenance of technical and clinical documentation. You will work closely with colleagues across product development, clinical affairs, marketing and management — ensuring that compliance and quality are integrated into how we operate, without carrying the documentation burden alone.

This is an exciting opportunity for someone who enjoys collaboration, structure, and problem-solving in a high-impact, regulated environment.

Your Responsibilities

• Coordinate and maintain the Quality Management System (QMS) in alignment with ISO 13485.
• Support the organization in regulatory compliance and CE marking activities for our Class II medical device software.
• Facilitate and coordinate the preparation, review, and maintenance of technical documentation (e.g., Technical File, Design History File) and clinical documentation.
• Ensure that QMS processes (e.g., risk management, design control, CAPA, supplier management, document control) are understood and followed across teams.
• Work closely with colleagues to collect, organize, and validate input documentation — serving as the QA/RA link between departments.
• Participate in internal audits, management reviews and continuous improvement initiatives.
• Collaborate with our external QA/RA partner (Key2Compliance) to ensure alignment with regulatory requirements.

Your Profile

• Bachelor’s or Master’s degree in engineering, life sciences, or equivalent experience.
• Experience working with ISO 13485, MDR (EU 2017/745), or similar regulatory frameworks.
• Familiarity with medical device software (SaMD) is an advantage.
• Strong communication and coordination skills — you enjoy working with others to get documentation right.
• Detail-oriented, organized, and proactive, with a genuine interest in quality and compliance.
• Fluent in English (written and spoken).

At Diaverum we value diversity. We are committed to equal opportunities and to creating an inclusive workplace environment for all our people. We welcome applicants regardless of ethnicity, nationality, gender, gender identity, colour, religious beliefs, disability, sexual orientation, age or marital status.