Regulatory Affairs Specialist

Abbott Laboratories; Witney; On-site; GBP 35,000 - 55,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Specialist to join their Centre of Excellence in Witney. This role focuses on ensuring compliance with EU Medical Device Regulations and supporting cross-functional teams in regulatory matters. The ideal candidate will possess a degree in Science or Engineering and have experience in Regulatory Affairs within the Medical Device field. Join a company that is dedicated to improving the quality of life for people with diabetes through innovative glucose monitoring systems. Enjoy a competitive salary and a comprehensive benefits package tailored to your needs.

Benefits

Defined-contribution pension scheme

Share ownership scheme

Private healthcare

Life assurance

Flexible benefits scheme

Qualifications

• Degree level education in Science or Engineering is preferred.
• Previous experience in Regulatory Affairs within Medical Devices is essential.

Responsibilities

• Maintain Technical Files to comply with EU Medical Device Regulations.
• Provide regulatory support for new product introductions and design changes.
• Identify and assess changes in Regulation, Standards, and Guidance.

Skills

Regulatory Affairs

Technical Documentation

EU Medical Device Regulations

ISO 13485

Cross-functional Team Collaboration

Education

Degree in Science or Engineering

Job description

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 has 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:

1. Work with cross-functional teams to provide regulatory support for new product introductions as well as on-market design changes.
2. Create, modify and maintain Technical Documentation demonstrating compliance with regulatory requirements within the EMEAP region.
3. Provide regulatory support to the business in sustaining compliance with new and revised requirements under MDR and IVDR.
4. Work within the Regulatory Intelligence process to identify and assess changes in Regulation, Standards, and Guidance within the EMEAP region.
5. Support the Regulatory Affairs team in external interface activities with regulators, Notified Bodies, and Trade Associations.
6. 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.