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Regulatory Affairs Associate (Spanish Speaking) Pencoed United Kingdom,  

Posted on : 05 April 2017

Project Description

ID  2017-4167 Job Locations  GB-Pencoed Posted Date  4/4/2017 More information about this job: The Company: Ortho Clinical Diagnostics (Ortho) is a leading provider of in vitro diagnostic products and services, offering accurate, timely, and cost-effective solutions for screening, diagnosing, monitoring and confirming diseases. The company is a strong, highly competitive organization with approximately 4,500 employees worldwide, and sales, marketing and logistics on six continents. Ortho was recently acquired by the Carlyle Group, a highly respected global asset management company, as an independent, freestanding company. With new leadership and accelerated investment in research and development, Ortho is well positioned for growth as a leading player in the global diagnostics market, tapping into rising demand for sophisticated medical diagnostic products and services worldwide. The Career Potential: Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That s something we can all take pride in as we take this journey together.   The Opportunity: We are seeking a Regulatory Affairs Associate to join our team in Pencoed. You will manage the coordination, compilation and submission of regulatory applications to regulatory agencies and work closely with associates in preparing regulatory submissions. The Responsibilities: Interpret regulatory requirements and determine strategy to obtain registrations. Independently make decisions regarding work processes or operational plans and schedules in order to achieve department objectives Represent Ortho to domestic and international regulatory agencies. Interacts with agency and affiliate personnel to expedite pending applications, resolve regulatory matters and manage development meetings for regulatory submissions. Works independently to identify and obtain data needed to support regional regulatory strategies Provide guidance to business partners regarding regulatory requirements including indications of risk and approximate timing for approvals for planning purposes Complete administrative activities related to maintaining compliant regulatory status for currently marketed products, which includes the maintenance of technical and design history files, review and approval of labeling and promotional materials and regulatory assessment of changes. Participate in departmental initiatives, such as process improvement and streamlining   The Individual: Education and experience - essential Degree level educated Minimum 2 years  progressive experience gained within a regulated healthcare industry Sound working knowledge of Microsoft Office, Word and Excel   Education and experience - desirable Degree in a scientific discipline Regulatory affairs experience in a medical device/IVD regulated industry Additional language: Spanish Alternate working hours: 10:00  18:00.  #LI-JS1 Equal Opportunity: At Ortho Clinical Diagnostics, we are proud of the empowering, inclusive and innovative culture we are growing. Our team is passionate about our work, and brings deep knowledge, industry experience and diverse thinking that drive results, making Ortho a place to grow your career.    Ortho Clinical Diagnostics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by law. 


GB Pencoed

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