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Regulatory Affairs Officer Liquids Netherlands, Netherlands,  

Posted on : 22 March 2017

Project Description

The position One of DORC’s major product groups consists of liquid products that are used by eye surgeons worldwide to perform eye surgery. The Regulatory Affairs Officer Liquids supports the projects for DORC’s liquid products through guiding the project team to generate the required documentation. You perform the review and approval of all documentation that is needed to allow for the liquid products to be marketed worldwide. You ensure that these products receive a timely approval from the applicable regulatory authorities based on the current regulatory requirements. You continuously anticipate on applicable standards and legislation such that these products can be manufactured according to the applicable standards and legislation and can be marketed worldwide. Hierarchically you report to the QA/RA Director and functionally to the Strategic Product Management Director Liquids and you work closely together with the Project Manager Liquids.     Responsibilities Responsible for giving advice, performing the review and approval of the project plans for new liquid products or changes to existing liquid products; Ensures that all project documentation is delivered according to the applicable law and legislation for medical devices and pharmaceutical product; Is also responsible for timely execution of the advice, review and approval tasks; Supports the project manager liquids in generating the project planning and reports periodically on progress of the assigned tasks; Evaluates which registration and quality system requirements there are per specific country and region; Keeps contact with the applicable regulatory authorities and or distributors in case of ongoing registrations; Analyze and anticipate on applicable medical and pharmaceutical standards and requirements such that the supplied products are conforming to the applicable (inter)national requirements (for instance: 510(k), PMA, establishment and product listings, etc.).   Job requirements Bachelor or University degree in Biotechnology, (bio)pharmacy, chemistry or chemical technology; Experience with international medical/pharmaceutical law and legislation; 3-5 years relevant experience in a multidisciplinary project team in a production environment; Excellent English language skills both verbal and in writing; Knowledge ofthe EU medical device directive and pharmaceutical law and legislation; Solid knowledge on the requirements for sterilization practices, bio compatibility and clinical evaluations.     We offer We offer a challenging position in a fast growing organization with unique products within ophthalmology, a pleasant work environment and excellent compensation and benefits. About D.O.R.C. Worldwide D.O.R.C. International, founded in 1983, has a leading position within ophthalmic surgery. We develop and manufacture innovative high quality disposable, re-usable instruments and FDA Approved Vitrectomy/Phaco systems that are sold in more than 80 countries. D.O.R.C. is a dynamic and innovative enterprise with subsidiaries in the USA, UK, Sweden, France, Germany, Spain, Austria, Dubai. In total more than 450 employees work for D.O.R.C. of which 275 at Head Quarters in Zuidland, The Netherlands. More information? For more information about this position please contact Jolien Meijer (Global Recruitment), tel. no. 0181-458080. Interested? Are you interested in this position? Please send a short motivation letter and your CV by clicking on the Apply button above or click HERE



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