Regulatory Affairs Director - USA, United Kingdom - Newton Colmore Consulting Ltd

Tom O´Connor

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Tom O´Connor

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Regulatory Affairs Director - Medical Devices - De Novo - San Diego


A new and well-funded Medical Devices company, based in San Diego, is looking for a Regulatory Affairs Director to take up a leadership position in the business and help navigate the company through the De Novo pathway.

The technology will address conditions that will result in saving many lives around the world. It is a novel technology that is really exciting and using the latest AI techniques to save lives.


You will be based on-site in San Diego and lead a team of Medical Devices and Software Engineers to continue with this development.

While also guiding the company through the De Novo pathway and FDA 510k submissions. Due to this, you must had successfulled a Medical Devices company through the De Novo pathway previously.


The company is funded and backed up by a entrepreneur who has a successful track record in starting up globally successful Medical Devices, so they know what needs to be done to make this company a success.


Newton Colmore Consulting is a specialist recruitment company within the Medical Devices, Scientific Engineering, Data Science, Machine Learning, Scientific Software, Robotics, Science, Electronics Design, New Product Design, Human Factors, Regulatory Affairs,Quality Assurance and Field Service Engineering sectors.


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