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Senior Regulatory Affairs Specialist
4 months ago
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 a portfolio of cutting-edge medical devices & IVDs, leading regulatory activities for new product introductions and significant on-market changes for the Europe, Middle East and Africa (EMEA) region. You will work with the Regulatory Affairs Manager, as part of a global team, to develop and implement strategies that will ensure the timely introduction of new products onto the international market in a fast-paced environment. You will coordinate and oversee preparation of complete and scientifically sound regulatory submissions and support interactions with the Notified Body and country regulatory contacts to resolve issues arising during the regulatory submission review process to ensure a timely approval process.
We’re hiring a Senior Regulatory Affairs Specialist to join the EMEAP regulatory affairs team, which is growing to meet the demands of the business and to support a strong product pipeline.
Core Job Responsibilities
Formulate, develop and manage business critical regulatory strategies for the EMEA region. Act as the regulatory subject matter expert in design control projects, assessing changes and managing roll out programs for existing products and new launches. Become a technical expert in ADC devices and support interactions with EU Notified Body Manage the creation and development of EU & UK Technical files in accordance with MDR 2017/745 & IVDR 2017/746. Provide support and guidance to more junior team members. Identify and implement process improvements and efficiencies per the global regulatory affairs strategy.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 Regulation (2017/745) and/or the IVD Regulation (2017/746).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. 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
