Ortho Clinical Diagnostics

Regulatory Affairs Associate

Job Locations GB-Pencoed
Posted Date 1 month ago(24/1/2018 4:43 PM)
Job Country
United Kingdom

The Company

Ortho Clinical Diagnostics (Ortho) is a global leader of in vitro diagnostics.  Ortho serves two primary industries in the medical field: clinical laboratories, by producing platforms and assays that test for a variety of diseases, conditions, and substances; and immunohematology, by providing the means to ensure blood transfusion recipients receive appropriate and compatible blood.


With a history of more than 75 years, Ortho is a pioneer in life-impacting advances in diagnostics. Worldwide across hospitals, hospital networks, blood banks and labs, Ortho’s high-quality products and services enable health care professionals to make better-informed treatment decisions. Headquartered in Raritan, NJ, Ortho Clinical Diagnostics has approximately 4,300 employees serving customers in more than 120 countries.


Ortho is recruiting and retaining the best and brightest around the world. People, who are performance driven, want to make a difference and who help Ortho grow their leadership position in a changing marketplace. The power to reimagine starts with empowered people, who are empowered to grow and given the chance to succeed in ways they hadn’t thought possible before.


Ortho’s purpose is simple: to improve and save lives with diagnostics. They do that by reimagining what’s possible. It’s what defines them. It’s the Ortho difference.


Ortho is an independent company, sponsored by The Carlyle Group, one of the world’s largest and most successful investment firms. The company's executive leadership team has extensive diagnostic experience and a strong heritage of driving market change and innovation. Ortho is a strong brand with solid positions in attractive, growing segments and regions.

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.


Ortho is known in the industry as a leader in customer service and support.  Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do.  It’s who we are.  If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

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
  • Second language in Chinese or Spanish is preferred but not required



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.

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