ofertas de empleo de Responsable garantía calidad en Life sciences
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1 trabajos encontrados de Responsable garantía calidad en Life sciences
16 diciembre 2020
Randstad Professionals , Barcelona (Barcelona)
Be part of a constanly growing biological multionational. We offer attractive conditions and the opportunity to build a professional career. Our client, an international biotechnology company, is looking for a REGULATORY AFFAIRS SPECIALIST for a permantent project in the outskirts of Barcelona, Spain. This position provides effective regulatory support for company¿s manufactured products and customer¿s products. Prepare and submit the documentation according to the corresponding legislation for the different countries. Be responsible for the implementation of new regulatory requirements. Key Accountabilities - Prepare the required documentation to obtain the CE mark, FDA or other country registrations for the company¿s manufactured products or customer¿s products in accordance to the current legislations. Communication and maintenance of products with Spanish authorities. - Support customers with any regulatory aspect. - Follow-up and resolve the requirements emerged in the registration procedures. - Maintain technical files as necessary to sustain product approval. - Review product materials, labeling and/or specification sheets for compliance with applicable regulations and customer¿s policies. - Be part of the CFT projects as the RA representative. - Support internal and external audits, validations and product¿s risk analysis. - Follow management indicators/metrics for the proper performance of the department and apply, if necessary, the appropriate corrective actions. - Support the Market Surveillance Department in the compilation of information for the Post Market Surveillance. - Recommend and manage, if applicable, changes to company procedures/documents (quality system and compliance) to comply with current regulations, guidelines and/or standards. - Provide support to Customer Service regarding import/export of the products. - Ensure effective partnering and collaboration with R&D, Quality Operations, Design Quality and Operations to meet project goals, maintain compliance, and complete defined regulatory submissions. - Ensure that all documentation is RA reviewed before it is shared externally with regulators and/or customers. - Collaborate with other QRA groups, R&D, and Operations to ensure successful Regulatory Inspectionsleer más