Snabbfakta
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- Mountain Ash
Ansök senast: 2024-12-22
Lead Clinical Research Associate - Sponsor Site
Walker Cole International is searching for a Clinical Specialist for a rapidly developing healthcare company specialising in developing medical devices and services globally. As a Clinical Specialist, you will be responsible for assisting in the planning and execution of clinical projects.
Key Responsibilities as the Clinical Specialist:
* Assess the clinical intelligence to develop local, regional, and global clinical strategies
* Evaluate the clinical environment and provide internal guidance to ensure product compliance throughout its lifecycle (concept, development, manufacturing, marketing)
* Provide clinical evaluations and post-market clinical follow-up – (PMCF) for proposed products
* Train stakeholders on current and new regulatory requirements to ensure organisation – wide compliance
A successful Clinical Specialist will exhibit:
* Knowledge and experience with ISO 13485, FDA, ISO 14155, ISO 14971, 93/42/EEC MDD &2017/ 745 MDR
* Strong communication skills to liaise with stakeholder groups
* Strong project management, writing, coordination, and execution of regulatory items
Clinical Specialist I Medical Device I Communication I ISO 13485 I FDA I ISO14155 I ISO 14971 I 93/ 42/ EEC MDD & 2017/ 745 MDR I Clinical Trials I Regulatory I International
