Quality & Regulatory Manager (QARA)

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Our client is a medical device company with Offices around Europe servicing international markets. On behalf of the Spanish operation, which is part of the Group, we are recruiting a Regulatory & Quality Manager (RAQA) - Management Representative responsible for the implementation of regulatory, compliance, quality assurance and quality system requirements for all relevant medical devices manufactured by the business near Madrid, whilst supporting the implementation of the group common QMS and corporate strategy and for:Ensuring the processes required for the Quality Management System (QMS) are establishedReporting to Top Management on the effectiveness of the QMS and the need for improvement andPromoting awareness throughout the organization of applicable regulatory and QMS requirementsAct as the point of contact for the business' certification body, Notified Body and National Health Competent Authorities and support the maintenance of Technical Files, Design Dossiers and Device Master Records, including certification and all other important documentation for the business product portfolio.Act as person responsible for regulatory compliance (PRRC)Act as the Technical Responsible (Responsible Person) for the manufacturing and importation of Medical Devices in Spain.This role may require occasional travel within Europe.Key Role Responsibilities: To ensure MR responsibility is fully discharged including management reviews, CAPA management, complaints investigation and so forth.To maintain compliance and improvement to the business QMS and quality, including the risk management programs.To advise and act on implications of the new or amended standards relevant to the medical devices manufactured by the business.To provide quality assurance support to the production, development and commercial teams, agreeing priorities and clearly conveying project timelines, risks and opportunities.To maintain notified body approval for the business' portfolio of medical devices.To ensure the technical files, design history records and device master records are in a permanent state of audit/inspection readiness.To plan and coordinate internal, supplier and external audits as required..To support the registration of products as required.To provide input to critical metrics and management reports.To provide appropriate input budget and forecast development.To maintain and continually seek to improve established QMS, including certifications.To maintain a performance and improvement culture and share best practice where possible.To act as Responsible Person (Technical Responsible) as defined in the RD1591/2009 for the manufacturing and importation of medical devices and as consequence assuming the following specific responsibilities:Direct supervision of the activities of manufacturing and importationVerify that the manufactured and imported devices comply with the applicable regulation requirements: o For the manufactured products: compliance with the essential requirements and that the products have been submitted to the corresponding conformity evaluation assessments. o For the imported products: having the mandatory authorizations, declarations, certificates and reports, suitableness of the labelling and instructions for use, inclusion of data, documents and sentences necessary for its distribution in Spain or Europe. Supervise the document archive of the manufactured, imported, marked or serviced.Review and evaluate the incidents related with the manufactured and imported products in terms of vigilance and have the resources for its communication to the Health Competent Authorities.Be the contact person with the Health Competent Authorities and collaborate with them for the implementation of the appropriate measures like product market withdrawal.Provide to the Health Competent Authorities, when required, the documentation supporting the product conformity according to the applicable regulation.Preparation and market communication of the products class IIa, IIb.Preparation and supervision for the register of the class I products.Preparation of the Manufacturing and Importing License and direct supervision of the Clinical Investigations. Supervision of the advertising and promotion product messages.

To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales