Lead Clinical Research Associate - Sponsor Site

Posted 2 days ago by Walker Cole International Ltd

Location:
Mountain Ash, Rhondda Cynon Taf

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 

Type:
Permanent
Contract Length:
N/A
Job Reference:
1708
Job ID:
222522847
Applications:
Less than 10

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