Medical Clinical Reviewer
3 days ago
**Tasks**
- We are currently looking for a Clinical Reviewer to aid in completing Audits, Inspections, and Training for clients to help ensure that our clients meet international requirements.
- Assessment of manufacturer’s clinical evaluation reports and corresponding documents according to the authorized scopes of all medical devices
- Identification when additional clinical or scientific input is required for the assessment of the clinical evaluation conducted by the manufacturer and identify appropriately qualified external clinical expert
- Training of external experts in the relevant requirements of applicable Directives and Regulation and guidance documents and standards
- Scientifically evaluate, judge and, if necessary, challenge the opinion presented by the external clinical expert on the requested special clinical or scientific input
- Review and scientifically challenge the clinical relevant pre-clinical and clinical data contained within the clinical evaluation, and any associated clinical investigations and make a recommendation to the notified body’s decision maker
- Consider any opinion derived from any relevant consultation procedure described within the relevant legislative framework related to clinical evaluation with authorities or expert panel
- Draw up records and reports demonstrating the result of the relevant conformity assessment activities
**Qualifications**
- Qualified Physician or adequate medical education with certified specialization in a medical field
- Minimum 4 years of relevant experience in the field of healthcare products with 2 years of experience in the assessment of clinical data for medical devices
- Clear and articulate presentation ability with excellent communication skills
- Travelling will be required within ASEAN, largely Thailand and Malaysia, occasion travel to USA and Europe
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