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1 trabajos encontrados de Responsable registros / regulatory affairs

  • Regulatory Affairs Manager

    14 febrero 2020

    Randstad Professionals , Barcelona (Barcelona)



    Multinational laboratory equipment company Multinational laboratory equipment company 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. ¿ Prepare international registration documentation (technical and legal) for the customer¿s products. ¿ Support customers with any regulatory aspect. ¿ Follow-up and resolve the requirements emerged in the registration procedures. ¿ Support internal and external audits, validations and product¿s risk analysis. ¿ Follow management indicators for the proper performance of the department and apply, if necessary, the appropriate corrective actions. ¿ Support to the Market Surveillance Department in the compilation of information for the Post Market Surveillance. ¿ Act as main company point of contact for all REACH and related legislative matters. ¿ Coordinate efforts associated with the preparation of REACH regulatory documents or submissions. ¿ Recommend changes to company procedures in response to changes in regulations or standards. ¿ 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. ¿ Prepare Safety Data Sheet for the different products.

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