Medical Device Regulatory Executive

CK Group are recruiting for a Medical Device Regulatory Executive to join a company in the healthcare industry at their site based in Ware on a contract basis for 6 months.

Salary: Up to £569 per day through an umbrella company

Medical DeviceRegulatory Executive Role:

• Preparation of high quality technical file documents for Medical Devices
• 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

Your Background:

• Experienced in Medical Device regulatory affairs
• 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.

Company: Our client is a global healthcare company, taking on some of the world's biggest healthcare challenges.Location: This Medical Device Regulatory Executive role will be based at our clients site in Ware, Hertfordshire.

Apply: For more information, please contact the Key Accounts Team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 52011.

Please note that the successful applicant will be required to engage via an FCSA-accredited and CK-approved umbrella company and the rate of pay indicated is an umbrella rate.