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Regulatory Consultant for FDA Compliance (Medical Device - ETCO₂ Adapter)
Description: We are developing a small, non-invasive accessory device called SnapCap that adapts standard oxygen face masks for capnography monitoring (ETCO₂) via standard male luer-lock sample tubing. The product is currently in its final design iteration and has been successfully tested for waveform capture. We are seeking a regulatory consultant with experience in FDA submissions and classification to: Assess whether SnapCap qualifies as a Class I 510(k)-exempt medical device Confirm FDA classification pathway (Class I or II) Guide us through registration and listing (if exempt) Help prepare compliant labeling and Instructions for Use (IFU) Advise on any necessary quality documentation for low-volume initial production Ideal candidate: Familiar with ISO standard for luer connectors and small-volume medical accessories Strong experience with Class I/II FDA device registration or 510(k) Able to provide recommendations that align with limited startup resources Deliverables: Classification memo or regulatory summary Label and IFU guidance or template Registration support Optional: Help identifying a manufacturer compliant with FDA standards