Medical Device Regulatory Executive

Medical Device Regulatory Executive

Clinical Life Sciences Pharmaceuticals

Location

Contract Contract

Reference HMR20W

Date Posted

Consultant


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]


Medical Device Regulatory Executive

Clinical Life Sciences Pharmaceuticals

Apply now

Less than an hour left to apply

Quick Apply

Already a member?

Yes, send me relevant communications
I accept the terms and conditions and privacy policy of CY Partners.


Related Vacancies

QA Officer

Biotechnology Chemical Clinical Life Sciences Pharmaceuticals

LocationNorth East

Salary£20-35K

ContractPermanent

An exciting opportunity has become available for Quality Assurance Officer within a leading pharmaceutical organisation, who are based in North East England. The role involves a range of QA activities and performing…

Clinical Laboratory Scientist

Biotechnology Clinical

LocationYorkshire

ContractContract

A global leader in medical diagnostic and global clinical trial testing services is looking to recruit a Clinical Laboratory Scientist to join their team. Working under the Senior Clinical Laboratory Scientist, the…

Senior Manager

Pharmaceuticals

LocationAbingdon

Salary£50,000 - £60,000

ContractPermanent

We are currently looking for a Senior Manager within API Development to work at an established Pharmaceutical CMO in Oxfordshire. The role involves project and line management, as well as providing technical…