SENIOR MDR REGULATORY AFFAIRS / QUALITY SPECILIST CONSULTANT_MD AND MDSW (BACHELOR'S DEGREE OR POSTDOC)
Descripción de la oferta de empleo
Senior MDR Regulatory Affairs The company will contact the candidates who meet the requirements and will evaluate them Tasks Be autonomous in the leadership and execution of projects to obtain CE marking of products.
Report weekly to your superior on the progress of the projects.
Establish the most suitable regulatory strategy for the customer.
Development of the customer's QMS documents and support in their implementation.
Development with the client of the TD of the product.
Interactions with ON.
Periodic meetings with client for the progress of each project and for the resolution of doubts or explanation of concepts.
Development of web publications related to technical aspects of your position.
Development of presentations for congresses Tipus de relació professional.
Contracte Tipologia de contracte.
Indefinit Núm.
Hores setmanals.
40h Horari.
8 a h de L a V online job 100% Retribució brut anual.
€ Formació reglada requerida.
m.
Doctorat - m.
Doctorat - cc de la vida i de la salut Licenciado o Post Doc- en Ciencias de la Salud MDR , MDCGs - Medical device, medical device software - ISO , ISO , IEC - ISO - development and implementation of QMS, RA and MDSW specific documents.
- Experience in verification and validation processes, including biolocompatibility product evaluation.
Experience in biocompatibility.
- Establishment of regulatory strategies.
Evaluation and classification of products.
- Development of TDs, for submission to NB.
Adaptation of documentation according to NBs requirements and available manufacturer's information.
- Support in the elaboration of CEP, CDP and CER.
- Knowledge in the review of documents required for clinical research applications.
- Valorable experiencia en auditoría.
6 years Advanced English Communication skills, proactive, high degree of autonomy.
Disponibilidad para viajar según necesidad en territorio nacional y ocasionalmente EU.
€ (including telecommuting allowance) negotiable according to value.
Detalles de la oferta
- Sin especificar
- En toda España
- Sin especificar - Sin especificar
- 25/06/2025
- 04/01/2026
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