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Regulatory Affairs Manager

Mon, Jun 13, 2022

Blue Note Therapeutics is a prescription digital therapeutics company singularly dedicated to transforming mental health care for cancer patients. We aim to make mental health care available to any cancer patient at any time by merging deep scientific and clinical expertise, neuroscience, and digital innovation.  Working closely with leading cancer centers, community oncology and teams of patients, Blue Note is developing clinically validated prescription digital therapeutics to help reduce anxiety, depression and other distress related to cancer. For more information, visit us at www.bluenotetx.com.

We have an immediate need for a Senior Regulatory Affairs Manager to help develop and implement the regulatory strategy, submit premarket submission, and manage the lifecycle of a product/product development in concert with the Director of Regulatory. This role requires someone with a strong background in medical device regulatory affairs. You will apply your knowledge of medical device regulations and standards to the development of digital therapeutics.  This role includes support and execution responsibilities and requires someone who is skilled at writing and filing of Pre-Submissions, Premarket submissions (e.g., 510(k) and/or De Novo Classification Request), regulatory strategies, and periodic reporting. 

Summary Of Key Responsibilities

Qualifications and Skills

Education and Experience 

Computer Skills                   

To perform this job successfully, an individual should have knowledge of Microsoft software applications, internet capabilities, and virtual team applications.  

Physical Demands/Work Environment

While performing the duties of this Job, the employee may be regularly required to sit; stand or remain stationary for extended periods of time and use hands and fingers as well as talk and hear. Reasonable accommodations may be made for individuals with disabilities to perform the essential functions.

Requirements for Remote Work:

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