Clinical Affairs Specialist
CK Group are recruiting for a Clinical Affairs Specialist on behalf of a medical diagnostic company. This role will be based at their site in Gateshead and is a permanent role with Mon-Fri day time working hours.
Role:
This position will be responsible for ensuring that
products and training materials are developed and maintained in line with current medical, analytical, and regulatory guidelines.
Job Specification
Responsibilities:
- Develop an in-depth technical understanding and expert knowledge of the clinical use of the entire product range.
- Promote the distribution of clinical knowledge throughout the company.
- Perform and maintain comprehensive literature reviews for entire product range.
- Generate and maintain IVDR compliant technical documentation.
- Produce, maintain and curate technical training materials.
- Take ownership of predefined projects, such as clinical studies and development projects.
- Provide occasional onsite support at customer sites in the UK and internationally.
- Educated to degree level or above in Biomedical and Biological Sciences with an understanding of In Vitro Diagnostics and how they affect patient care.
- Experience in a field such as Medical writing, Risk assessment, training, diagnostics laboratory, IVDR, ISO15189 or ISO13485 or Medical Statistics.
- The ability to produce high quality technical documentation is essential.
- Excellent presentation skills.
- Ability to have high level technical conversations and convey a clear message to a range of healthcare professionals and business colleagues.
- Self-motivated with excellent time management and organisational skills.
For more information, or to apply for this Clinical Affairs Specialist
position please contact Mary Bolt on 01246 457729. Please quote job reference 159073 in all correspondence.
It is essential that applicants hold entitlement to work in the UK.
INDLS