Clinical Analyst
Agfa
- Gent, Oost-Vlaanderen
- Vast
- Voltijds
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.
- 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
- 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