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Posted: Thursday, September 28, 2017 9:30 PM

Responsible for managing BSI activities in the assigned specialist technological area of sterilization and microbiology, ensuring the utilisation of appropriate technical expertise for reviewing medical devices technical documentation and quality systems and attending assessments as technical expert or providing expert briefing. The individual is also responsible for planning, reporting and performing of audits of clientsA? management systems ensuring compliance with regulatory and voluntary requirements. Essential Responsibilities:Manage between 50 and 100 (depending on complexity and risks) allocated clients, with responsibility to deliver an agreed revenue. The job holder is expected to maintain a position of leadership in the assigned industry sector, recognised and acknowledged by external agencies (Medicines and Healthcare Regulatory Agency, Food and Drug Administration, USA, Trade Associations) as an expert.Responsible for planning, reporting and performing of audits of clientsA? management systems ensuring compliance with regulatory and voluntary requirements. This aspect of the job involves significant travel and time away from home.Conduct comprehensive in:depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and practised technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work.Must be competent to analyse risks against benefits, in an environment where a favourable decision from the notified body will potentially lead to very large commercial benefits for the device manufacturer. Must also be capable and competent to make recommendation to withdraw a certificate and deny a device market access.Determines when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective.Manage major clients to ensure medical devices group maintains customer satisfaction and profitability. Client management will include major client management of global device manufacturers with thousands of individual of devices. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilisation of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client.Responsible for financial and regulatory performance of all managed activities to include confidentiality, impartiality and conflict of interest requirements.Design Dossier Reviews A? Initial reviews completed within 5 working days, full review completed within 30 working days.Certificate Recommendations A? Ensure that no unsafe certificates are issued.Briefing notesA?Provide adequate technical briefing notes, where required, for technical visits.ProfitabilityA? Maintain control over costs of all visits and reviews to achieve satisfactory profits.Regulatory ComplianceA? Ensure all activities exceed the regulatory and accreditation requirements expected of the group.Major Account ManagementA? Manage a portfolio clients including major accounts.Education/Qualifications: Bachelor degree required or equivalent level in Microbiology with a minimum of 3 years in:depth experience in working as a microbiologist in the manufacture of sterile products (medical devices or pharmaceuticals).Customer and Personal Service A? Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.Administration and Management A? Knowledge of business an

Source: https://www.tiptopjob.com/jobs/72687872_job.asp?source=backpage


• Location: Northern Virginia

• Post ID: 38479892 nova
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