As a QM/RA professional at our Valencia site, you will be a key member of our Germany-based Quality Management & Regulatory Affairs team. You will ensure compliance with international quality standards and regulatory requirements and continuously develop and improve all related processes.

Key Responsibilities

• Implement and maintain a quality management system compliant with ISO 15189, including:

• Supplier management

• Event handling

• Change control

• Act as the on-site lead for internal and external audits by accrediting agencies

• Identify and evaluate local regulatory requirements for clinical diagnostic laboratories

• Support internal stakeholders in implementing QMS and regulatory requirements

• Create and maintain technical documentation for in vitro diagnostic medical devices

• Deputize for the head of department as local PRRC in accordance with §15 IVDR

• Manage communication with local regulatory authorities to maintain licensure as required

• University degree in life sciences or another relevant scientific discipline

• At least two years of experience in quality management and regulatory affairs related to medical devices or in vitro diagnostic medical devices

• Working knowledge of ISO 15189 and MDR or IVDR

• Strong analytical mindset and structured approach

• Proactive, solution-oriented, and collaborative working style

• Business fluent in English and Spanish

With employees from over 50 nations, CENTOGENE is a truly international company with offices is in Rostock, Berlin, Delhi, Boston, Valencia, Belgrade, and São Paulo.

We were born to help diagnostic patients with rare disease and today we evolved to help patients of all clinical specialties to make bold progress with guided solutions for physicians, their patients and pharma partners.