The client needs a senior level regulatory / clinical consultant that can help to revise the client’s regulatory plan and 510(k) strategy for a device that is getting ready for electrical safety testing and may be about 6 plus months away from being ready for submission. The consultant will need to be able to evaluate the product, strategy and plan and develop plans for clinical studies (high-level overview) which may involve clinical studies and/or hospital exemptions. They will need to detail the risks, action items and detail the clinical study strategy. The device is not a new device, but rather adds a cooling element to help reduce neurological damage and reduce risk of infection during surgeries. Additionally, they would like the consultant to also have experience with setting up/conducting meetings with the regulatory authorities (FDA and Health Canada) to review regulatory and clinical strategy/planning. The client envisions using the consultant a few times over the next 6 months for about 1-2 weeks (about 30 hours) at a time.
Remote: Regulatory / Clinical Consultant (221953)