This offer is managed as an Urgent Incorporation Process (PIU) for the company CMG MEDDEV which needs to fill 1 vacancies of the profile: 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 17:00h de L a V online job 100%
Retribució brut anual: 40.000
Requisits:
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 2017/745, MDCGs
Medical device, medical device software
ISO 13485, ISO 14971, IEC 62304- ISO 10993 - 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.
40.000 (including telecommuting allowance) negotiable according to value.