Overview

Reference Number: JO-2106-471093
Clinical Affairs Officer
Rate: £42,000 – 45,000
Job Type: Permanent
Location: Gloucester

Clinical Evaluation/Clinical Affairs Officer
Suitable Locations – Swindon, Bath, Bristol, Gloucester, Cardiff
Industry: Medical Devices
Salary: Up to 45k
Benefits: Pension 9%, Annual Pay Review, Bonus, 2 days’ home working, Career Development, Relocation assistance

Our client is a global Medical Devices manufacturer specialising in cutting edge Medical implants used within the Healthcare sector. They now have an exciting opportunity for a Clinical Evaluation/Clinical Affairs Officer to join their market leading organisation. Reporting to the Head of QA/RA and Clinical Affairs, the purpose of this role is to assist in meeting the clinical data and regulatory compliance needs for the company, from a clinical aspect,

Key Responsibilities:

– Work alongside the Clinical Operations team and CRO to contribute to Clinical Protocols, data analysis, Clinical Study Report review, and handling any issues arising during the trial (such as device deficiencies and SAEs) within the company.
– Support design control process in areas such as risk, labelling review and clinical data.
– Coordination of Clinical Evaluation using literature review, PMS, PMCF, pre-clinical and clinical data
– Creation of the Clinical Evaluation Report, and update to it during the product lifecycle (e.g. update to literature search or when new Clinical data exists).
– Cross-functional collaboration with Marketing, Regulatory and Legal teams

Experience Requirements:

– Experience of a similar role within a medical device company
– Experience of working with clinical trial applications
– Experience in Clinical Evaluation
– Life science or medically related degree

This is a permanent role with a respected global business. As well as a competitive salary and benefits, you will work with an innovative and progressive company that value their employees. If this role is of interest, please send your CV to George.Danchie@cpl.com or call 01189594990 for more information

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