Senior Specialist Regulatory Affairs

Abbott ,
Witney, Oxfordshire
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Job Description

Senior Specialist Regulatory Affairs Abbott Diabetes Care Witney, Oxfordshire Competitive Salary + Excellent Benefits Abbott Diabetes Care designs, develops and manufactures leading-edge glucose monitoring systems and test strips for use in both home and hospital settings. Our product portfolio includes Freestyle Libre, a recently launched system that is revolutionising how people with diabetes around the world monitor their glucose levels. We are passionate about doing work that improves the quality of people's lives. We currently have an opportunity for a Senior Regulatory Specialist to join our team, based in Oxfordshire, supporting the significant manufacturing capacity expansion underway at the Witney site plus other Operational and R&D projects. The Senior Regulatory Specialist is 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. This role 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. The Senior Regulatory Specialist will coordinate and oversee preparation of complete and scientifically sound regulatory submissions and lead interactions and discussions with the Notified Body and country regulatory contacts to resolve issues arising during the regulatory submission process. Main Responsibilities as Senior Regulatory Specialist: EMEA Registrations and European Directives: + Formulate, develop and manage a program to enable all 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. Qualifications and Required Experience: + 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). As you'd expect from an innovative global healthcare company, we offer an excellent starting salary, and a competitive range of benefits including a defined contribution pension scheme, share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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