Regulatory Associate - Witney, United Kingdom - Abbott Laboratories

Abbott Laboratories
Abbott Laboratories
Verified Company
Witney, United Kingdom

3 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

Abbott is about the power of health. For more than 130 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.


World Leader in Glucose Monitoring, Abbott Diabetes Care designs, develops and manufactures glucose monitoring systems for use in both home and hospital settings.

We have a Centre of Excellence in Witney for the development and manufacture of electrodes and biosensors used by patients and healthcare professionals for the day-to-day management of diabetes.

The site has been instrumental in the research, development and manufacture of the FreeStyle Libre Flash Glucose Monitoring System as well as exciting developments in the Libre family including FreeStyle Libre 2, FreeStyle Libre 3 and the Libre Sense system.

We are passionate about doing work that improves the quality of people's lives.


Primary Job Function:


As the Regulatory Associate, you will be responsible for supporting the EMEAP Regulatory operations team and to support an efficient program to ensure that all Europe, Middle East and African (EMEA) registrations, including Technical Files and country specific registrations of Abbott Diabetes Care products are achieved to an agreed schedule.

Work within the UK Regulatory Affairs team to support and implement strategies that will ensure the timely introduction of new products onto the international markets well as maintaining existing products on market.

Interact and work with country regulatory contacts to resolve issues arising to support existing and new products in the markets.


Core Job Responsibilities:


  • To be a key part of the regulatory affairs team supporting ADC
  • To provide support and assistance with RA projects within EMEAP
  • Support a roll out program for existing products and new launches.
  • Support ADC manufacturing sites from a RA perspective, including changes requests and documentation updates.
  • Manufacturing site audit support as required
  • Support with technical file updates as required
  • Undertake specific projects as assigned by the line manager to the agreed timescales.
  • Ensure that all documentation is correctly completed to a high standard of clarity.
  • Maintain awareness of regulations and guidelines governing the company and communicate their impact on the registrations.
  • To open and maintain regular communications with any contacts requiring any regulatory involvement.
  • Maintain regulatory knowledge of changing regulations within EMEAP, support assessments of changing regulations.
  • Demonstrate compliance with EHS regulations and Abbott standards by adhering to EHS systems, programmes and procedures, being accountable for the Health & Safety of themselves and others and by highlighting where improvements to EHS performance can be made.
  • Check and complete own training records/status in a timely manner and performs functions in a manner that is compliant with the ETMS/ISO training system.
  • Adhere to all company policies and procedures and training requirements.
  • Maintain a high standard of housekeeping and ensure that all areas are clean and tidy in line with 5S principles.

Minimum Education**:

Educated to degree level or equivalent preferably in a Scientific or Engineering discipline.


Minimum Experience/Training Required**:

At least 1 year experience within a regulated industry (including internships).


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.

Of course, things are a little different right now, but in general, we like to help our employees live life to the fullest, and therefore we offer a range of optional initiatives for you to get involved in, including onsite allotments, couch to 5k campaigns, beekeeping, yoga and more
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