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:

1. Assess the clinical intelligence to develop local, regional, and global clinical strategies.
2. Evaluate the clinical environment and provide internal guidance to ensure product compliance throughout its lifecycle (concept, development, manufacturing, marketing).
3. Provide clinical evaluations and post-market clinical follow-up (PMCF) for proposed products.
4. Train stakeholders on current and new regulatory requirements to ensure organisation-wide compliance.

A successful Clinical Specialist will exhibit:

1. Knowledge and experience with ISO 13485, FDA, ISO 14155, ISO 14971, 93/42/EEC MDD & 2017/745 MDR.
2. Strong communication skills to liaise with stakeholder groups.
3. Strong project management, writing, coordination, and execution of regulatory items.