Emea Regulatory Affairs Leader - Barcelona Indiferente

EMEA Regulatory Affairs Leader:ConfidencialLa del trabajo.:EMEA Regulatory Affairs Leader - Barcelona Nombre dEl puesto: EMEA Regulatory Affairs Leader Empresa: Confidencial País: España Ciudad/Localidad/Barrio: Barcelona Fecha: 07/10/2016 ID: 76037958 GooglePerform duties Authorized Representative in maintaining regulatory compliance for products marketed within the European Union with primary emphasis on communications to the Competent Authorities. Monitor and audit complaints European subsidiaries directly reporting in ETQ. Coordinate vigilance reporting and recall activities in Europe. Main Functions: Provide requested documents to each subsidiary/distributor in the European Community on a case-by-case basis and in accordance with National laws, including Italian registrations .Responsible to ensure the adequacy of all labeling and IFUs to European and International Standards. Maintain and update EU Health Authorities databases for Medical Device placing in the market and commercialization, as well as international internal databases on registrations. Supervise EMEA Submissions and Recall Team(s). Report all adverse incidents as well as recalls to the Competent Authorities. Follow-up with communications and final reports as needed. Notify the Competent Authorities of any changes to the place of business or address of the manufacturer. Give support by reviewing the Medical Device Directive, proposed EU Medical Device Regulation, applicable standards, and national laws for any new or updated revisions. Communicate updates to Global Headquarters' regulatory staff and European subsidiaries. Perform Quality audits of EU subsidiaries. Responsible for participating in internal and external departmental audits and any responses to cited issues being the ownership of corrective actions stemming from these audits.9. Provide regulatory/quality support to the Barcelona facility or other subsidiaries during inspections by notified bodies or other international regulatory bodies. Profile: University degree in health of life science related subject. 3 years in practical international medical device regulatory experience . Certified Quality Auditor (CQA) preferred. Fluent in English & Spanish. Attention to detail, communications, organizational and management skills, initiative and flexibility, used to work with deadlines, stress resistant-

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