Your ResponsibilitiesAs 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 requiredYour profile* 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