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Regulatory Affairs Officer 1. HOVEDSTADEN. Dinamarca

Trabajos en Dinamarca (HOVEDSTADEN) de Analistas de sistemas



Clasificación del trabajo: Profesionales científicos e intelectuales : Profesionales de tecnología de la información y las comunicaciones : Desarrolladores y analistas de software y multimedios : Analistas de sistemas.
Arbejde, der forudsætter viden på højeste niveau inden for pågældende område : Arbejde inden for informations- og kommunikationsteknologi : Udvikling og analyse af software og applikationer : Systemanalytikerarbejde.

Descripción de la oferta de trabajo:
Do you have experience with RF, EMC and Safety of electronic medical devices? Would you like to use your skills and knowledge in an International set-up? Do you want to be part of a highly qualified Regulatory Affairs team in one of the world’s leading companies within hearing solutions? Then we might have an exciting opportunity for you in our company. The Challenge You dare to make a difference and together with ambitious and talented colleagues, you will be part of a dynamic department. You must manage and support RF, EMC and Safety strategy in relation to choice of test methods, reuse of approvals and how to deal with various countries. You will participate in different RF, EMC and safety projects as RA project manager or RA project member. Your responsibility will be regulatory RF, EMC and Safety approvals for R&D projects. You will: •Identify relevant RF, EMC and safety standards for the product •Support the project in interpretation of RF/EMC & Safety standards with respect to EU and US •Communicate details about documentation and test samples needed to the projec •Create, review and approve regulatory documentation •Collect test samples and arrange and participate in external testing •Contact to test house •Take lead on RA aspects if any problems occur, finding possibilities and solutions •Maintain registrations in IT system (i.e. PRADA and Documentum) •Support RF approvals for the rest of the world Oticon offers an exciting position within a dedicated company, which is characterized by trust and openness. You will support the business in order to ensure, on behalf of our customers, that the products are the most attractive. You will be given the opportunity to put your mark on the job and many opportunities for personal and professional development. Since Oticon experiences growth, there will be good career opportunities within the organization. You will be referring to the Head of Regulatory Affairs. Your qualifications and experience You have a relevant university degree and competences within RF (i.e. Bluetooth), EMC and Electrical Safety, prepare regulatory strategies and negotiate with different authorities about RF, EMC and Safety approvals. You have experience with accepting/ rejecting RF, EMC and Safety documentation from projects. Create, review and approval of RA documentation according to defined procedures is also one of your competences. Your self-motivation combined with your business oriented perspective results in your ability to organize and plan your tasks. It is important that you are focused, can prioritize and keep calm when deadlines are tight. You are fluent in English, both written and spoken. In other words, you have a desire to support and enrich Oticon´ s culture. The team You can be part of the success by joining the RA department, which consist of 11 highly dedicated colleagues and is part of the Quality Assurance & Regulatory Affairs department. The RA department is responsible for regulatory strategy for each project throughout the product development process. Among other tasks, the team is managing classification activities, risk management file processes, device and facility registrations, radio approvals, electrical safety approvals plus standard and regulation requirements. Furthermore, the team is involved in internal audit and system compliance according to EN ISO 13485 and FDA 21 CFR 820. The team is also continuously involved in improvement projects. You would love to work in a worldwide leading company, where knowledge sharing and mutual professional respect makes it fun and meaningful to work. Do you want to join the team? Then send your application no later than June 28th 2017. If you would like to learn more about the job, you are welcome to contact Signe Linneboe, Recruiting Partner, +45 4149 9523. We look forward to hearing from you.

Servicio de empleo de origen: AMS, Servicios Públicos de Empleo, Dinamarca.

País del trabajo: Dinamarca.

Región: Hovedstaden.

Ver 1161 ofertas de trabajo en "HOVEDSTADEN" (Dinamarca).

Fecha de inicio: 12/06/2017.

Nº de vacantes: 1.

Nivel educativo requerido: Sin especificar.

Tipo de contrato: Jornada completa.

Duración del contrato: Indefinido.

Cómo solicitar el puesto:
Signe Linneboe

Empresa: OTICON A/S.

Teléfono: 39177100.

Fax: 39277900.





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