Quality Assurance

hace 2 semanas

Madrid, España SpotLab A tiempo completo

We are looking for an experienced and talented Quality Assurance & Regulatory Affairs Manager, who will contribute to Spotlab's mission of achieving regulated artificial intelligence for medical image diagnosis.

Spotlab is transforming the healthcare medical diagnosis industry. It brings artificial intelligence to diseases that are not yet in the digital world. We use smartphones to transform microscopes and rapid diagnostic tests into smart and connected devices. Our goal, democratize quality diagnostics everywhere

Spotlab has received more than 10 international awards, including the Seal of Excellence of the European Union, being one of the most innovative start-up companies based on breakthrough innovations with scale and impact potential. We are a multidisciplinary orquestra with gender parity and up until now, 8 nationalities, where developers, engineers, doctors, business managers, etc. with different professional backgrounds interact and complement each other.

**Responsabilities**
- Monitor conformance under Quality System guidelines, compliance with ISO standards (mainly ISO 13485), in the operational processes on a daily basis
- Monitor the implementation of Standard Operation Procedure (SOP) and update the SOPs in collaboration with other functional departments as needed
- Ensure full documentation on QA-related issues throughout the operational procedure and full communication with all functional stakeholders
- Participate and support documentation for the regulatory audit, internal audit, management reviews, and supplier evaluation meetings.
- Provide feedback to help drive continuous improvement through the routine analysis of the CAPA program
- Achievement of ISO 13485 and ISO 9001 certification.
- Interlocution with the Competent Authorities.
- Ensure compliance with current regulations (IVDR, MDR, GDPR).
- Contribute to the design of the company's regulatory strategy.
- Supporting the process of obtaining the CE Marking of In Vitro Medical Devices, including artificial intelligence algorithms for medical diagnosis, following the IVDR by Conformity Assessment mechanisms.
- Market surveillance of regulated products. Reporting to authorities.
- Experience in the development, implementation and evaluation of Quality Management Systems.
- Experience in the IVD (In Vitro Diagnostic Medical Device) and/or MD (Medical Device) medical sector and its regulations (IVDR and MDR).
- Experience in interlocution with Notified Bodies, and with the AEMPS (Spanish Agency for Medicinal Products Regulatory Affairs).
- Experience in the registration and post-market surveillance of In Vitro Diagnostic Medical Devices (IVDR) and/or Medical Devices (MDR).
- Experience in SaMD (Software as a Medical Device) regulation.
- Good communication skills, teamwork.
- Accuracy, decisiveness, organization and excellent attention to detail.
- Advanced verbal and written English and Spanish

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