Ubicació: Barcelona (Espanya)
Tipus de Contracte: Indefinit
Jornada: Jornada completa
Sector: Salut
Vacants: 1
Salari: 39000/42000€ Brut/anyDisciplina: I+D
Modalitat de treball: En remotBARCELONA ACTIVA gestiona ofertes d'empreses que necessiten cobrir vacants de personal. Les posicions que es publiquen no són per a Barcelona Activa. NOMÉS ES TINDRAN EN COMPTE LES CANDIDATURES QUE ARRIBIN PER AQUEST CANAL. El Servei de Cerca de Treballadors/es s'adreça a aquelles empreses del territori que necessiten incorporar nous professionals als seus equips i ofereix suport en la identificació de les vacants, el reclutament de personal i la preselecció de candidatures que s'ajustin als perfils sol·licitats.
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
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
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