Title: Regulatory Executive
Pay Rate: £588.28 Per Day Via Umbrella / PAYE Option is Available
Start: 1st of November 2021
Preparation of high quality technical file documents for Medical Devices (including those related to combination products), using varied information sources and liaising closely with other GSK personnel to ensure accuracy of such records. Work to agreed deadlines, with ability to respond readily to changing events and priorities.
Tasks will include, but may not be limited to:
• Assist in compiling Annex I and II checklists for devices
• Assist in regulatory strategy planning for technical file submission
• Assist in risk assessment process
• Update SOPs and/or create new SOPs to detail ways of working
• Engagement with Notified Body organisations
Experienced in Medical Device regulatory affairs
Good written and oral communication. Demonstrated ability to focus, work with attention to detail and retain critical information.
Demonstrated team working skills, with the ability to establish strong relationships and liaise effectively with GSK sites worldwide.
Demonstrated effective time management skills.
Demonstrated problem solving skills.
Be proficient in the use of IT packages such as Word, Excel and Documentum/Veeva Vault systems.
Degree in Engineering, Pharmacy, Chemistry or related discipline.
Global experience, (with a specific focus on EU requirements), in Medical Devices and Drug Device Combination products.
Working knowledge of MDR implementation with a focus on clinical requirements.
Prior experience in MDD technical dossier submission, Notified Body interactions and preparing technical files for Medical Devices (including CER) and managing the related responses to questions. Lifecycle management of Medical Devices / Combination products