Senior Regulatory Specialist - Witney, United Kingdom - Abbott Laboratories

Abbott Laboratories

Verified Company

Witney, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

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

You will be responsible for managing an efficient program to ensure that all Europe, Middle East and Africa (EMEA) registrations, including Technical Files and country specific registration of Abbott Diabetes Care products are achieved to an agreed schedule.

You will work with the UK Regulatory Affairs Manager to develop and implement strategies that will ensure the timely introduction of products onto the international market.

You will coordinate and oversee preparation of complete and scientifically sound regulatory submissions.

You will lead interactions and discussions with the Notified Body and country regulatory contacts to resolve issues arising during the regulatory submission review process to ensure a timely approval process.

Core Job Responsibilities:

Formulate, develop and manage a program to enable al EMEA registrations are completed efficiently and to an agreed schedule.
Manage a roll out program for existing products and new launches.
Manage the creation and development of Technical files for both the IVD and Medical Devices Directives.
Provide guidance to Regulatory Specialists in coordinating the preparation of regulatory submissions.

Sample Requests and Label Copy:

Manage a program to ensure efficient scheduling of all sample requests.
Review all baseline labelling, marketing and training materials for regulatory compliance within EMEA.

Projects:

Undertake specific projects as assigned by the line manager to the agreed timescales.

General:

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.
Open and maintain regular communications with any contacts requiring any regulatory involvement.
Responsible for maintaining the effectiveness of the Quality System at the site in accordance with Abbott Corporate requirements and applicable regulations.
Ensure 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.

Position Accountability / Scope

Responsible for ensuring the timely registration and registration maintenance of all current and new ADC products with the correct regulatory authorities
Efficient and accurate management of various systems to enable traceability of records for future reference and use.

Minimum Education**- Educated to degree level or equivalent preferably in a Scientific discipline e.g. Chemistry, life Sciences, Biology.

Minimum Experience/Training Required**- Educated to degree level or equivalent preferably in a scientific discipline e.g. Chemistry, life Sciences, Biology.

Experienced in regulatory submissions for in vitro diagnostic devices and/or medical devices.
Experience of working within the requirements of ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).

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