Medical Regulatory Expert Needed – SFDA MDMA Licensing Support for Blood Collection Tubes
Budget: $2 – $8 USD
Description:
We are seeking a qualified and experienced medical regulatory consultant with a solid background in SFDA (Saudi Food and Drug Authority) regulations to assist in reviewing and completing the required documentation for obtaining a Medical Device Marketing Authorization (MDMA) license.
Scope:
The product in focus is single-use plastic blood collection tubes. Our goal is to prepare and submit a full or partial MDMA application package that complies with SFDA standards.
Key Details:
The manufacturing equipment is supplied by an international company that has not previously operated in Saudi Arabia.
The manufacturer only provides technical and administrative documentation related to his equipment, and does not provide product-level test results.
The selected expert will be responsible for:
Reviewing the attached SFDA licensing requirements document.
Confirming the ability to complete all or part of the required documentation.
Sourcing or generating test results and clinical data for similar products using academic references, public databases, or their professional network.
Providing or developing sample forms, procedures, or protocols where actual data is unavailable, as the factory is not yet operational.
Required Deliverables (attached)
If you have experience in compiling SFDA-compliant MDMA documentation, particularly for IVD or medical disposables, we encourage you to apply.
Please begin your proposal by mentioning your previous experience with SFDA-MDMA and then by indicating whether you can complete the full documentation or specify which parts you are equipped to handle.
Ideal Skills and Experience:
- Familiarity with SFDA regulations and requirements
- Experience in preparing technical files and risk management plans for medical devices
- Knowledge of quality management systems and certification processes
- Background in medical devices, particularly in low-risk categories
We are seeking a qualified and experienced medical regulatory consultant with a solid background in SFDA (Saudi Food and Drug Authority) regulations to assist in reviewing and completing the required documentation for obtaining a Medical Device Marketing Authorization (MDMA) license.
Scope:
The product in focus is single-use plastic blood collection tubes. Our goal is to prepare and submit a full or partial MDMA application package that complies with SFDA standards.
Key Details:
The manufacturing equipment is supplied by an international company that has not previously operated in Saudi Arabia.
The manufacturer only provides technical and administrative documentation related to his equipment, and does not provide product-level test results.
The selected expert will be responsible for:
Reviewing the attached SFDA licensing requirements document.
Confirming the ability to complete all or part of the required documentation.
Sourcing or generating test results and clinical data for similar products using academic references, public databases, or their professional network.
Providing or developing sample forms, procedures, or protocols where actual data is unavailable, as the factory is not yet operational.
Required Deliverables (attached)
If you have experience in compiling SFDA-compliant MDMA documentation, particularly for IVD or medical disposables, we encourage you to apply.
Please begin your proposal by mentioning your previous experience with SFDA-MDMA and then by indicating whether you can complete the full documentation or specify which parts you are equipped to handle.
Ideal Skills and Experience:
- Familiarity with SFDA regulations and requirements
- Experience in preparing technical files and risk management plans for medical devices
- Knowledge of quality management systems and certification processes
- Background in medical devices, particularly in low-risk categories
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