Your Responsibilities
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
Your 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