Education Requirements

Required

• A Master’s degree in pharmaceutical sciences, or biomedical engineering, or biological sciences, or a related field is required.
  
• A bachelor's with an additional 2 years of experience may be considered in lieu of a master’s degree.
  

Experience Requirements

Required

• At least 5 years of experience in Quality Assurance for medical devices and/or other health products is required
  
• Experience in in-vitro diagnostics and in applying relevant regulatory frameworks, including but not limited to IMDRF, WHO Prequalification, EU MDR 2017/745, EU IVDR 2017/746, FDA 21 CFR Part 820, or equivalent standards, is required
  
• Proven track record evaluating products' QA submissions from manufacturers' dossiers is an asset.
  
• Experience in Compliance with Good Manufacturing Practices requirements for suppliers and manufacturers is an asset
  

• In depth technical review of submitted QA documentation per product based on the GDF QA Policy.
  
• Check and verify the manufacturer’s QA and regulatory documents for compliance.
  
• Validate the authenticity and validity of ISO 13485/9001 or equivalent and other relevant certifications. Perform necessary technical due diligence on certifications and verification of accreditation status, including assessment of risks and implications
  
• Confirm that certificates were issued by accredited notified bodies and are still valid.
  
• Draft and submit questions for clarification as needed.
  
• Assess any additional evidence submitted in response.
  
• Prepare comprehensive QA evaluation reports for each product reviewed, including risk assessments and formal recommendations.
  
• Provide technical advice to GDF management on quality assurance risks, regulatory compliance trends and related issues, as may be required
  
• Data Security: Submissions may contain sensitive or proprietary information requiring the consultant to comply with GDF’s data handling and confidentiality policies.