Medical Device Regulation (MDR) senior regulatory executive
GSK has a range of medical devices and combination products which are impacted by the MDR and is establishing both an implementation and lifecycle team to address the new requirements. GSK is seeking a temporary worker to work with the team in implementing the MDR requirements.
Work will include, but may not be limited to:
Preparation of high-quality Clinical Evaluation Reports (CER) and technical files 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:
• Drafting CER documentation
• Reviewing clinical trial material to understand if the MDR requirements are met
• 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 or working
• Engagement with Notified Body organisations
Experienced in Medical Device regulatory affairs – including responsibility of non-clinical and clinical requirements.
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.
Be proficient in the use of IT packages such as Word, Excel and Documentum systems.
Demonstrated problem solving skills.
Degree in Engineering, Pharmacy, Chemistry or related discipline.
Global experience, (with a specific focus on EU requirements), in Medical Devices and CER for Medical Devices.
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.
All profiles will be reviewed against the required skills and experience. Due to the high number of applications, we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply.