Clinical Specialist (Sustaining Engineering Group)

Co-ordinates and leads 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.

• 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
• 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.
• Optimize both expenses and resource allocation to achieve optimal profit ensuring fit with both short- and long-term goals.

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