, is a division of the Agfa-Gevaert Group which is headquartered in Mortsel, Belgium and traded on Euronext Brussels (AGFB). At Agfa HealthCare, we support healthcare professionals across the globe to transform the delivery of care. Our focus is 100% on providing best-of-suite Imaging IT software solutions that enable secure, effective and sustainable imaging data management. From product development to implementation, our unified Enterprise Imaging Platform is purpose-built to reduce complexity, improve productivity and deliver clinical value. We use our proven track record as an innovator, our in-depth medical knowledge and our strategic guidance to help healthcare providers achieve their clinical, operational and business strategies.
The main focus of this role is to assess clinical safety risk for complaints and problems in case of failures in the delivery of our IT products and services to our customer install base. The individual will focus on potential and actual risk analysis with the support teams or problem analysts and appropriate customer contacts for clinical evaluation. The Clinical Analyst decides if a Health Hazard Evaluation (HHE) is required and will own and drive the risk assessment.
The Clinical Analyst works closely with the Product Quality Manager and is part of the respective Product Quality Team (PQT) to provide clinical input to that team for specific Problem Records. The incumbent must possess strong clinical domain experience in Radiology and / or Cardiology.
Main Responsibilities:
Review and assess complaints flagged for actual or potential harm for incident reportability according to the regulations and decide if a full Risk Assessment (HHE) is required
Create Problem Records for these situations and own the clinical analysis. Provide input into problem record to accurately determine severity of problem.
Complete the Health Hazard Evaluation (HHE) as part of the risk assessment.
Clinical Analysts are available to all levels of support for consultancy on potential patient safety complaints
Provide clinical input into any Medical Device Recalls, or Correction and Removal plans as it relates to the Health Hazard Evaluation.
Provide input into IITS Problem Management process being a member of the Product Quality Team (PQT)
Maintain working knowledge of current products and solutions.
Competencies (skills, knowledge, behaviors):
Education, Experience and Skill Requirements:
Degree or Diploma in a Cardiology or Radiology technical field or an equivalent combination of education and experience
Degree or Diploma in a technological field or an equivalent combination of education and experience
3 or more years previous work experience in a clinical customer environment
Excellent computer skills including MS 365
Excellent oral, written and interpersonal communications skills
Proven organizational and time management skills
Demonstrated experience adapting to change
Strong customer orientation, interacting with both internal and external customers
Previous experience working in a global environment (networking and building relationships with individuals in remote locations)
Strong understanding of the regulated medical device environment.
Cooperation & Teamwork.
Precise and accurate
Quality and compliance minded
Other:
This description is not intended to be an exhaustive list of responsibilities for this position.
As such, additional activities & skills not listed here may be involved, and other duties as assigned by management may be required of the incumbent
