Abbott Senior Regulatory Specialist in Witney, United Kingdom
Abbott Diabetes Care designs, develops and manufactures leading-edge glucose monitoring systems and test strips for use in both home and hospital settings, and we have recently launched a new system that will revolutionise how people with diabetes around the world monitor their glucose levels. We are passionate about doing work that improves the quality of people’s lives.
Our Centre of Excellence in Witney for the manufacture of test strips and biosensors used by patients and healthcare professionals for the day-to-day management of diabetes have an exciting opportunity for a Senior Regulatory Specialist.
Reporting to the UK Regulatory Affairs Manager the Senior Regulatory Specialist role will focus on changing regulation within the Europe, Middle East, Africa and Pakistan (EMEAP) region. The primary initial focus will be transition to the EU Medical Device Regulation (MDR) and IVD Regulation (IVDR). Activities undertaken by this role may include:
Working within the Regulatory Intelligence process to identify changes in Regulation, Standards and Guidance within the EMEAP region. Working cross-functionally to review and gap assess new or revised requirements for impact on the Quality System, products and regulatory submissions. Enacting identified changes to align the business with new or revised requirements in a timely manner.
Manage the workflow for Regulatory Intelligence items progressed through the Regulatory Affairs department.
Create, modify and maintain Technical Documentation demonstrating compliance to regulatory requirements within the EMEAP region.
Support the Regulatory Affairs Manager in external interface activities with regulators, Notified Bodies and Trade Associations.
Provide regulatory subject matter expertise to support business activities as required.
The ideal candidate will be educated to degree level (or equivalent), preferably in a Science or Engineering discipline, and will bring previous experience of working within Regulatory Affairs in the Medical Device or IVD field. Alongside this, we are looking for candidates with a strong working knowledge of EU Medical Devices Directives, (90/385/EEC and/or 93/42/EEC and/or 98/79/EC), knowledge and understanding of the EU Medical Devices Regulations, (Regulation (EU) 2017/745 and 2017/746) and experience working within an ISO 13485 certified Quality System. Experience of working with regulatory frameworks outside the EU is desirable, but not essential.
In addition to a competitive salary, Abbott offers a highly attractive benefits package which includes a defined-contribution pension scheme, a share ownership scheme, private healthcare, life assurance and a flexible benefits scheme which you can tailor to your own requirements.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org