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Regulatory Affairs Associate Pencoed United Kingdom,  

Ortho Clinical Diagnostics (company)

Posted on : 20 March 2017

Project Description

The Company: 
  • Our company is a leading global provider of in vitro diagnostics. 
  • We have an established track record for providing high-quality products and services to the global clinical laboratory and immunohematology communities. 
  • Our company  has approximately 3,800 employees, serving customers in more than 120 countries.   
  • We are recruiting and retaining the best and brightest around the world. 
  • People who are performance driven, want to make a difference and who help us grow our leadership position in a changing marketplace. 
  • The power to re imagine starts with empowered people. 
  • People who are empowered to grow and given the chance to succeed in ways they hadn t thought possible before.   
  • Our purpose is simple: to improve and save lives with diagnostics. 
  • We do that by re imagining what s possible. It s what defines us.

The Career Potential: 
  • Our company  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 our company.
  • 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.
  • 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 our company 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 

Equal Opportunity: 
  • 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 company  a place to grow your career.  Our company  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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