Clinical Engineering Specialist
Our client are a global manufacturer of medical devices focusing on the Ostomy space. They are looking for a Clinical Engineering Specialist to provide input and co-ordinate clinical activities for the development of medical devices. The clinical engineering specialist will be working with new product development teams, develop clinical evaluation plans (clinical strategy) and clinical evaluation reports and be responsibility for any clinical investigations in line with pre and post market product launch requirements.
The Clinical Engineering Specialist will be responsible for Clinical input into change control activities, risk management activities (e.g. Product Risk Reviews), complaint evaluations, Health Hazard Evaluation (HHE), reviewing Advertising and Promotional Materials from a Clinical perspective and providing ad hoc clinical advice. Provide support for design history file/technical file remediation.
- Represent clinical affairs on core/project teams for product development and change control including risk assessments and 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
- 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
- Coordinates and /or participates in the timely execution of a clinical investigation from a clinical study plan to final clinical study report within the established timeline and budget.
- Supports the following activities including but not limited to: country and site selection, investigator meetings, CRF development, data review plan, database validations, data listing requirements and review, monitoring site start up, monitoring patient recruitment, preparation and /or review of appropriate clinical documents, Clinical Study Report development, CRF distribution, timely data collection, delivery of final database, etc.
- Communicates and works closely with other departments such as R&D, Regulatory Affairs, Quality Management and Marketing to ensure timely completion of clinical documents for Regulatory filings and clinical responses to health authorities.
- Leads ad-hoc strategic projects.
- Optimise both expenses and resource allocation to achieve optimal profit ensuring fit with both short- and long-term goals
- Ideally a Bachelor's Degree in Life Sciences, Allied Health, Pharmacy etc. or equivalent practical experience.
- Understanding of the clinical product development process trial
- Understanding of clinical trial process - the role may be required to support clinical trial activities
- Has demonstrated principled leadership and sound business ethics: shows consistency among principles, values and behaviours.
- Understanding of the medical device industry and of the pre-clinical, clinical, marketing and regulatory components.
- An understanding of clinical research, including the protocol/project relationship and key milestones
- Solid understanding of project planning and project management methods and the ability to apply them.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales