Australian Regulatory Consultant: Infant Sleep Product Compliance Review (ACCC & TGA)

Overview We are an Australian e-commerce business preparing to supply an infant sleep surface product to allied health professionals, primarily paediatric physiotherapists, for rental. Before we approach them, we need formal regulatory clarity on where our product sits under Australian consumer product safety law and the TGA framework. We are looking for a regulatory consultant or product safety auditor with genuine experience in Australian infant and baby product compliance to review our product's classification and give us a clear, written assessment we can stand behind. Physiotherapists need confidence that the product is compliant before they will stock or recommend it, so the quality and defensibility of this advice matters to us. This is a focused, well-defined piece of work with three deliverables. If it goes well, there is scope for ongoing advisory work as we expand the range and the supplier channel. About the product Our product is a contoured infant sleep surface designed to redistribute pressure away from flat spots onto the surrounding areas of the skull, supporting the natural development of a well-shaped head. It is used in the context of positional head shape concerns such as plagiocephaly and brachycephaly, commonly known as flat head. The product sits on top of a standard cot or bassinet mattress as an accessory and is not a standalone sleep product such as a cot, bassinet, rocker or inclined sleeper. The product is sold internationally and has been sold directly to end users in Australia since March 2025. It is an established product entering a new channel, so this work covers a product already in the market rather than a pre-launch concept. We make no medical claims. We do not claim to treat, cure, diagnose or prevent any condition, and we describe the product by its mechanical function rather than as a treatment. Confirming that this positioning keeps us outside the therapeutic goods framework is a key part of the TGA advice we need. Full product specifications, materials, dimensions and intended-use information will be shared with the selected consultant, under NDA if you prefer. Why we are hiring on Upwork This sits in a genuine specialist gap. Our questions cross consumer product safety law, mandatory standards and therapeutic goods regulation, and most general legal practices are not set up to give fast, commercial answers on niche infant product classification. We would rather work directly with someone who lives in this area than route it through a generalist firm. Upwork lets us find that specific expertise. We are looking for an auditor's mentality. Rather than a high-level opinion, we want you to work methodically through the Consumer Goods (Infant Sleep Products) Safety Standard 2024 (as amended) and, for each relevant requirement, answer four questions: a. Does this apply to our product? b. If it does, what do we need to do to meet it? c. Where do we currently stand against it? d. What testing, if any, does it involve? We would rather have a thorough, point-by-point assessment than a short summary that skips the detail. The three areas below are how we would like the findings structured. Scope of work We need a written regulatory assessment covering three areas. We have done our own preliminary research and hold a working position on each. We want an expert to confirm it, challenge it, or correct it with clear reasoning. Product classification review Determine whether our product is captured by the Consumer Goods (Infant Sleep Products) Safety Standard 2024 (as amended by the 2025 amendment). Our working position is that, because it is a sleep accessory placed on top of an existing mattress rather than a standalone sleep product, it may fall outside the scope of that standard. We need this confirmed or challenged with reasoning grounded in the standard's definitions and scope. ACCC standards and obligations assessment Set out what mandatory standards and obligations under the Australian Consumer Law do apply to the product, including any relevant requirements under the Consumer Goods (Infant Products) Information Standard 2024, such as warnings and safety information. If the safety standard does apply, we need to know specifically what that means for us in practice. TGA standing advice Confirm our standing from a TGA perspective on the basis that we make no therapeutic or medical claims. We want clear advice on what keeps the product outside the therapeutic goods framework, and where the line sits that we must not cross in our marketing and supplier communications. If your assessment concludes that testing is required, we want specifics rather than a general indication. For each test you identify, please tell us: The exact test, and the standard or clause it relates to, for example flammability, mechanical and structural, sleep surface incline, or materials and chemical testing. Where it can be carried out, ideally named accredited labs or testing providers we can approach in Australia. An indicative cost of that test, or a current quoted price from the provider you identify. Deliverables A formal written report setting out your findings and reasoning across the three areas above. This is the core deliverable. It must be professional, standalone and defensible, written so that we can provide it to a range of stakeholders, including allied health partners, distributors, insurers, and the ACCC if requested. Please cite the relevant standards, definitions and reasoning clearly so the report holds up to outside scrutiny. A plain-English summary of our compliance position that we can share with allied health professionals without handing over the full report. This will include marketing advice i.e what to avoid saying to not overstep compliance boundaries. A short list of recommended next steps, covering any testing, labelling or documentation. Where you recommend testing, include the specifics set out above: the exact test, where it can be done, and the actual cost. Who we are looking for Essential: Demonstrated experience with Australian consumer product safety law and ACCC mandatory standards. The ability to give clear, commercial, written advice, not only academic analysis based on experience. Highly valued: Familiarity with the 2024 infant sleep product standards Direct experience with infant, baby or nursery product compliance, or a closely related field such as medical devices or therapeutic goods. Experience advising on TGA classification and the line between general consumer goods and therapeutic goods. Knowledge of Australian product testing pathways and accredited labs. To be clear, we are not looking for a generalist lawyer or a broad compliance freelancer. We want someone who knows this specific area well. Engagement and budget Fixed price, structured around the three deliverables as milestones. Potential for ongoing advisory work as we expand the product range and the supplier channel. How to apply Please keep your proposal specific. We will prioritise applications that include: A short note on your relevant experience with Australian infant or baby product compliance, or closely related regulatory work. Examples or anonymised case references are welcome. Your initial read on our core question: would an accessory that sits on top of a mattress likely fall within or outside the Consumer Goods (Infant Sleep Products) Safety Standard 2024? One or two lines on your thinking is enough at this stage. Your proposed approach and a rough timeframe. We will provide supporting documentation so you understand our product and the current test we have had run on it in the UK as a starting position