Quality assurance & regulatory affairs specialist (ivd)

Who We Are

BioeXsen is the German commercial and regulatory partner of Bioeksen, a molecular diagnostics manufacturer operating under an ISO 13485-certified Quality Management System and serving customers in more than 70 countries."

As the sales and application partner of Bioeksen, we offer CE-IVDR-compliant diagnostic systems and reagents designed to deliver fast, accurate, and reliable results. Backed by a multidisciplinary team of scientists and commercial experts, we are committed to advancing healthcare through innovative diagnostic technologies.

Join us and be part of a team shaping the future of molecular diagnostics.

About the Role

We are looking for a Quality Assurance Specialist to join our team at our office in Germany. As a company operating in the IVD sector and placing quality at the core of our business processes, we seek a professional who will contribute to the effective implementation and continuous improvement of our Quality Management System (QMS).

This position will play an active role in document and record control (eQMS, management of measurement equipment calibration and maintenance processes, and ensuring compliance with ISO 13485 and IVDR requirements.

Key Responsibilities

Document & Record Management

• Manage document control processes through the electronic Quality Management System
• Ensure proper review, approval, issuance, distribution, and archiving of procedures, work instructions, forms, and records
• Manage document revision and change control processes

Equipment Calibration & Maintenance Management

• Maintain the list of measurement and monitoring equipment
• Establish and follow up calibration and preventive maintenance plans
• Coordinate internal and external calibration activities
• Review and archive calibration certificates and service records

QMS Compliance & Audit Processes

• Actively participate in internal audit processes
• Support supplier audits and follow up on nonconformities identified during audits
• Support preparation activities for ISO 13485 certification audits and inspections by Competent Authorities / Notified Bodies
• Follow up corrective and preventive actions (CAPA)
• Participate in risk analysis activities together with the quality team
• Work in close coordination with Bioeksen Türkiye’s Regulatory Affairs and Quality Assurance teams.

Regulatory Affairs Support

• Support registration and regulatory maintenance activities under IVDR 2017/746
• Maintain technical and regulatory documentation
• Support communication with Competent Authorities and Notified Bodies where applicable

Qualifications

• Bachelor’s degree or higher in Life Sciences, Biology, Molecular Biology, Biomedical Engineering, Biotechnology, Medical Technology, Pharmacy, or a related scientific discipline
• 3+ years in regulated medical device, IVD or life sciences industries
• Knowledge of ISO 9001, ISO 13485, ISO 14971, and IVDR 2017/746
• Experience in internal audit activities under ISO 13485 is preferred
• Experience in calibration processes and measurement equipment management
• Preferably experienced in electronic document management systems (eQMS/QDMS)
• Good command of written and spoken German and English
• Proficient in MS Office applications

Competencies

• High attention to detail and strong documentation skills
• Analytical thinking and problem-solving abilities
• Strong planning and organizational skills
• Team-oriented with a strong sense of responsibility
• Proactive approach to process improvement and compliance

At BioeXsen, we know that what makes us strong is our diversity.

Regardless of gender, age, ethnicity, belief, disability status, language, culture, or lifestyle, we value all applications with an equal and fair approach. We believe in the unifying power of science and adopt an inclusive and respectful work environment, embracing an equitable approach to ensure and maintain it.

Why Join BioeXsen?

• Opportunity to work in a growing IVDR-compliant diagnostics company
• Close collaboration with international Quality and Regulatory Affairs teams
• Direct exposure to ISO 13485, IVDR and Notified Body audit processes
• Opportunity to contribute to the development of quality systems in a growing organization