Medacs Healthcare is one of the UK's leading nursing and care agencies.
Our Client is looking for an experienced and dedicated Clinical Specialist to work in Deeside, Near Chester.
This is a full time permanent role.
Medacs Healthcare are recruiting, on behalf of their client, a qualified and experienced Clinical Specialist Nurse.
You will be co-ordinating and leading clinical activities on a project basis. This may include clinical representation on New Product Development Core Teams, development of clinical evaluation plans (clinical strategy) and clinical evaluation reports and responsibility for any clinical investigations in line with pre and post market product launch requirements. Clinical input and expertise will also be provided for change control activities, risk management activities (e.g. Product Risk Reviews), complaint evaluations, Health Hazard Evaluation (HHE) preparation, participating in project teams, reviewing Advertising and Promotional Materials from a Medical/Clinical perspective and providing ad hoc clinical advice to support other functions. Provide support for design history file/technical file remediation.
DUTIES AND RESPONSIBILITIES
Your key responsibilities will include :
* Represent clinical affairs on core/project teams for product development and change control including risk assessments and IFU development. Review and provide input into design history file remediation activities including design verification/validation, hazard analyses, product risk reviews and to prepare and/or update Clinical Evaluation reports
* Prepare and update Clinical Evaluation Reports for inclusion in the technical file in accordance with MEDDEV 2.7.1 and GHTF Guidance and internal SOP's. This will include preparing systematic literature reviews, complaint analysis and overall analysis of clinical evidence for presentation to the Clinical Evaluator
* Provide clinical input into Health Hazard analyses
* Provide medical review support for MRL approval for advertising and promotional material. Working closely with core/project team clinical members to ensure claims and intended use are accurately represented
* Support the complaint handling group, participating in Medical Device Complaint/Malfunction review, ensuring appropriate assessment and guidance in terms of reportability as required
* A full understanding of the clinical product development process trial
* An understanding of the clinical trial process - the role may be required to support clinical trial activities
* Works both as a team member and independently, engages and supports other members of the team and willingly accepts support when required. Is able to make decisions, in consultation, if required, and accept accountability.
* Willingly embraces change and the need to adapt to new circumstances. Takes an innovative approach while maintaining compliance.
* Can establish strong working relationships with clinical Investigators and key opinion leaders.
* Has demonstrated principled leadership and sound business ethics: shows consistency among principles, values and behaviors.
* Seeks and welcomes feedback, responds to coaching, takes action to change.
* Effective use of oral and written communication skills to influence, inform or guide others.
THE IMPORTANT BIT
The role offers an annual salary of £40,000 and is office based within Deeside, Near Chester.
HOW TO APPLY
Apply today by clicking the "apply for this job" button or alternatively please call Deborah Probyn on 01785 236 202.
ABOUT MEDACS HEALTHCARE
With a reputation for delivering high quality care for over 25 years, Medacs Healthcare is one of the UK's leading nursing and care agencies and we are the preferred supplier of agency staff to many NHS Trusts nationally. Medacs Healthcare is a healthcare recruitment agency for Registered General Nurses (RGNs), Registered Mental Health Nurses (RMNs) and Healthcare Assistants (HCAs). We are able offer you a fantastic variety of long and short term temporary nursing jobs.