Sener is currently looking for Senior Quality & Regulatory Compliance Manager to join our team at our Cerdanyola del Vallès work centre. In order to improve people's living conditions, we develop instruments for the automation of microbiology and molecular biology laboratory processes in the clinical and industrial fields, with which we streamline workflows. Among all of them, AUTOPLAK stands out, as it is one of our star products that contributes to improving laboratory efficiency and quality of service.
Ensure that manufacturing and quality processes comply with regulations.
Act as the regulatory contact with AEMPS and legal authorities and customers.
Responsible for FDA regulatory compliance, and generate and maintain TF, DHF and DMR.
Perform risk analysis and mitigation actions follow-up.
Evaluate the legal frame to commercialize in new countries and collect all the documentation needed.
Provide the needed information to legal representatives in each country to manage the issues found.
Requirements to be “Técnico Responsable” for Medical Devices (Spain – Real Decreto 1591/2009 and RD 192/2023).
Alternatively, equivalent professional experience in medical devices may be accepted by the Spanish Agency of Medicines and Medical Devices (AEMPS).
Knowledge of medical device legislation, including EU Regulations (MDR 2017/745 or IVDR 2017/746) and Spanish transpositions.
Understanding of quality management systems (ISO 13485).
Familiarity with risk management (ISO 14971).
Requirements for a PRRC (Person Responsible for Regulatory Compliance) – EU Regulation 2017/746 (IVDR)
A university degree in law, medicine, pharmacy or another relevant scientific discipline AND at least 1 year of professional experience in regulatory affairs or quality management systems related to IVDs. 4 years of professional experience in regulatory affairs or quality management systems related to IVDs (no degree required).
Expertise in quality management systems (ISO 13485).
Knowledge of perfo
📌 Senior Quality (España)
🏢 Sener
📍 España