Medical Device Regulatory Executive
Clinical Life Sciences Pharmaceuticals
CY Partners have an exciting opportunity for a Medical Device Regulatory Executive to join a leading global pharmaceutical company, based at their site in Hertford.
As a Medical Device Regulatory Executive, you will have the opportunity to work as part of a team implementing MDR requirements, preparing high-quality Clinical Evaluation reports and technical files for Medical Devices. As a Medical Device Regulatory Executive, you will liaise closely with colleagues to ensure accuracy of records, work to agreed deadlines and respond readily to changing events and priorities.
Additional tasks for the role may include:
• 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
Additional skills which would be desirable for this role include the following:
• 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.
This position is offered on an initial contract basis and is a unique opportunity for a Medical Device Regulatory Executive to expand on their experience and work with a global company.
For further information please feel free to contact Helen or at CY Partners on 0191 477 4733 or [email protected]