Regulatory Affairs Manager Orthopedics, Texas, USA

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Menlo Park is currently partnered on a high growth project for a rapidly expanding Orthopedic organisation in the USA. They are currently looking to treble their Headcount over the next 18 months and are currently recruiting for a Regulatory Affairs Manager to be based remotely in the USA.

Responsibility

Report into the Vice President of Global Quality and Regulatory
Responsible for FDA 510k submissions, registrations, complaints handling and design change reporting
Expand the companies International presence through obtaining the CE Mark, and Regulatory registration to MDR
Build a Regulatory affairs team and grow the function for the organisation
Work closely with the clinical team
Occasional travel the US HQ and International travel once the International business has grown

Requirements

At least 4 Years’ Medical Device Regulatory Affairs experience, Orthopedics a plus
Fluency in English is essential
Science related degree is highly desired but not essential
Highly motivated individual who is able to work cross-functionally and engage in a long-term growth project
Ideal candidate is someone looking for a growth opportunity

For further details on this Medical Device role, please use the Apply section. If you can specify a best time to talk, please do; we will get in touch when it suits you best. You will then be contacted by one of our specialist care consultants, who will provide you with further details about the role.

We have been voted as the Recruitment Agency of the Year at the General Practice Awards, so in dealing with us you’ll be in safe hands.

Please note, any contact is in the strictest confidence. We will not send your details to any organisation without your expressed consent to do so. If you would like to talk, please give us a call on +44 (0) 113 468 9231. We look forward to speaking with you.

For every placement we make, Menlo Park plants two trees – one on your behalf and the other on the surgery’s behalf. In planting two trees we offset 0.6 tonnes of CO2, the equivalent of driving 1,466 miles in a standard car – we want to contribute to help save the planet!