Senior Clinical Affairs Specialist- 9 Month Contract This position is responsible for providing support for assigned clinical projects.
These projects ensure product conformity of medical devices to EU MDD or MDR.
The Senior Clinical Affairs Specialist will provide support to the functional project teams leading to sound clinical documents for new and existing products/indications.
Key Responsibilities: Preparing, writing, editing, and reviewing Instructions for use (IFUs), Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post Market Clinical Plans (PMCFPs), Post Market Clinical Follow-up Reports (PMCFRs) and Summary of Safety and Clinical performance (SSCPs) Design, conduct and documentation of systematic literature searches in medical databases on products, specific indications, outcomes, or other topics.
Appraisal, grading, analysis and write up of all clinical data obtained through the systematic searches to establish clinical evaluation acceptance criteria and quantitatively compare subject device data to demonstrate compliance to relevant general safety and performance requirements (GSPRs).
Knowledge of risk management processes for medical devices (such as ISO *****) to provide clinical input and review to risk management personnel.
Knowledge and understanding of proposed and current global medical device regulations and guidance and the ability to relay the impact of such regulations and guidance internally and to clients.
Ensuring documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7.1 Rev. 4, (EU) MDR ********, relevant MDCGs, ISO standards).
Appraising, analysing and summarizing clinical data and preparing reports, figures, and scientific meeting presentations.
Client management tasks such as; project scoping and proposal writing, proposal management and scheduling, leading weekly progress calls with clients.
Key Requirements: At minimum a bachelor's degree or equivalent in medical-related field or life science/healthcare field.
Minimum 5 years of experience in a similar role in the medical devices industry Fluent written and spoken English.
Excellent communication & interpersonal skills Excellent attention to detail and execution of critical appraisal of information Knowledge of clinical research of medical devices (Good clinical practice principles: ISO ***** and relevant MDCG guidance) including preparing, writing, editing and reviewing clinical investigation documents such as Clinical investigation plans (CIPs), Investigator Brochure (IB), case report form (CRFs) For further information please contact Loretta Flynn Skills: clinical affairs medical writer medical devices ISO ***** EU MDR ********