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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
