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Regulatory Affairs Manager

Company: Charlton Morris
Location: Trenton
Posted on: November 21, 2019

Job Description:

Are you interested in working for a company at the forefront of the IVD industry? If so, then this role could be the one for you... As a specialist organization within the liquid biopsy arena, this company is expanding significantly due to the high demand for these products in the IVD space. Having already commercialized their technology and oncology portfolio, they are looking to grow their product portfolio and begin branching into other areas such as reproductive health. Using single-cell applications, this technology is able to identify CTCs for a range of cancer types; meaning detection is far quicker and ultimately patients receive the correct treatment in a more timely manner. As the Regulatory Affairs Manager, you'll be responsible for the following; Compiling documents required for FDA submissions (510K, IDE, Pre-sub), Maintain working relationships with all internal and external stakeholders from a regulatory perspective; most notable distributors to ensure they cooperate on all issues from licensing to new regulatory requirements, Maintain knowledge of new requirements released by the FDA, as well as implement and update the necessary procedures internally. These are just some of the things you'd be involved with. As a key player, in a smaller team, you will lay a pivotal role in the expansion of the company and its portfolio; offering great development prospects in the mid/long term. If you're interested, please get in touch directly at ben.paice@

Keywords: Charlton Morris, New York , Regulatory Affairs Manager, Executive , Trenton, New York

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