Job Title
We are seeking a seasoned Clinical Affairs Specialist to join our team. The ideal candidate will have a strong background in medical devices and clinical research, with excellent communication and interpersonal skills.
This is an exciting opportunity for someone who wants to make a meaningful contribution to the development of medical devices that improve patient lives.
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About the Role
* Provide support for assigned clinical projects, ensuring product conformity to EU MDD or MDR standards;
* Design, conduct, and document systematic literature searches on products, indications, outcomes, or other topics;
* Analyze and write up clinical data obtained through systematic searches;
The Senior Clinical Affairs Specialist will work closely with functional project teams leading sound clinical documents productionfor new/existing products/indications. Key responsibilities: - Preparing,writing/editing/reviewing Instructions For Use (IFUs),Clinical Evaluation Plans (CEPs),Clinical Evaluation Reports (CERs),Post-Market Clinical Follow-up Reports (PMCFRs)and Summary Of Safety And Performance(SSCP). - Conduct/write/documentation literature review/design ,clinial data analysis&writingclinical reports(KeyResponsibilities)
- Knowledge of risk management processesISO(MedicalDevices); - Understand propose/current global regulations/guidance apply rules clients.