Job Description

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

• 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