Regulatory Affairs Specialist
Witney, Oxfordshire
Abbott Diabetes Care designs, develops and manufactures leading-edge glucose monitoring systems and test strips for use in both home and hospital settings. We are passionate about doing work that improves the quality of people’s lives.
Our Centre of Excellence in Witney for the manufacture of biosensors and test strips used by people with diabetes and healthcare professionals for the day-to-day management of diabetes have an exciting opportunity for a Regulatory Specialist.
The Regulatory Specialist will focus on changing regulation within the Europe, Middle East, Africa and Pakistan (EMEAP) region. The primary initial focus will be maintenance of Technical Files to the EU Medical Device Regulation (MDR) and IVD Regulation (IVDR). Activities undertaken by this role may include:
Work with cross functional teams to provide regulatory support for new product introductions as well as on-market design changes.
Create, modify and maintain Technical Documentation demonstrating compliance to regulatory requirements within the EMEAP region.
Provide regulatory support to the business in sustaining compliance with new and revised requirements under MDR and IVDR.
Working within the Regulatory Intelligence process to identify and assess changes in Regulation, Standards and Guidance within the EMEAP region.
Support the Regulatory Affairs team 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 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.
