Clinical Evaluation/Clinical Affairs Officer

null, England, gb
Company: CPL
Category: Management Occupations
Published on 2021-07-28 06:06:29
Clinical Evaluation/Clinical Affairs Officer
Gloucestershire – Home and office based
Permanent
Competitive Salary + Benefits: Pension 9%, Annual Pay Review, Bonus, 2 days' home working, Career Development, Relocation assistance

We are looking for a Clinical Evaluation/Clinical Affairs Officer to join a global Medical Devices manufacturer specialising in cutting edge Medical implants used within the Healthcare sector. Reporting to the Head of QA/RA and Clinical Affairs, the key 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:
- Coordination of Clinical Evaluation using literature reviews, PMS, PMCF, pre-clinical and clinical data
- Work alongside the Clinical Operations team and CRO to contribute to Clinical Investigation Protocols, data analysis, Clinical Study Report review, and handling any issues arising during the trial (e.g. device deficiencies and SAEs)
- Support the design control process in risk, labelling review and clinical data areas.
- 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 Regulatory, Marketing and Legal teams

Key Requirements:
- Experience within Medical Devices in a similar role
- Experience in Clinical Evaluation including writing Clinical Evaluation Reports, Clinical date reviews and literature reviews.
- Life science or medically related degree

If this role is of interest, please send your CV to Hanna.Poole@cpl.com or call 0118 952 2793 for more information.

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