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URGENT:Medical Device Regulatory Affairs Specialist _Part-time 40-60 %

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Kelly Scientific Geneva is looking for a great company a Regulatory Affairs Specialist _Medical Device_ TEMP 6-9 months min. Part-time 40-60 %.
=> URGENT : Available Immediatly.

• Deputy Regulatory Affairs / Quality Assurance
• Plan regulatory actions of assigned projects for drug, medical devices, biocide or cosmetics and manage timely dispatch of regulatory data packages
• Write, compile and update dossiers according to international guidelines (ICH) and national requirements
• Prepare Submission (payments to authorities, cover letter, application form, organize legalization)
• Work closely with internal and external customers on the timely implementation of product changes and response to the upcoming questions
• Approval of Promotional Material
• Regulatory lifecycle management (tracking of regulatory history, filing and update of RA database)
• Ensure compliance in regards to the requirements of the markets (e.g. product information, specifications)
• Preparation of labeling, package leaflet and SmPC for the submissions
• Keep updated on the latest regulatory requirements (regulatory Intelligence)
• Communicate EU document preparation standards for variations (e.g. Manufacturing validation)
• Proactively address industry trends and opportunities and communicate these to the appropriate management functions
• 3-5 years of work experience in RA within the pharmaceutical industry
• Combined experiences with CMC document preparation and medical device experience of the international markets is highly desirable.
• Effectively work with a wide variety of personnel across diverse teams and functions within the company and external parties.
• Good command of English (written and spoken) is a must, good German speaking skills are an asset
Mathilde Dromard, Consultant Professional Staffing Life Science | PhD in Biology and Health | Kelly Services (Suisse) SA, Rue du Rhône 114, 1204 Genève, Switzerland


Region: Genève
Vertragsart: Befristet
Kategorie: Strategie & Management;
Veröffentlicht am: 22.09.14
Beschäftigungsart: Teilzeit
Job Nummer: JO-1409-15687
Abteilung: Kelly Services, Inc. in Switzerland is a leader in providing innovative workforce solutions. Kelly offers a comprehensive array of custom-designed outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and permanent basis. Kelly provides employment to more than 200 people in over 40 branches and specialist department throughout Switzerland.

Kelly specializes in providing professional/technical workforce solutions, with local expertise. These solutions include Finance, Science, and Medical. Kelly has a rich history in developing our solutions to address the workforce challenges of these communities, with expert staff dedicated to providing integrity and technical competency to ensure high performance, and proven results from its specialty talent.Link megjelenítése" width="0" height="0" />
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