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Regulatory Lead

Fri, May 21, 2021

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 Regulatory Lead to further build Blue Note’s regulatory affairs function.  This includes defining and implementing the regulatory strategies for the development, submission, clearance/approval, and life-cycle management of our portfolio of Prescription Digital Therapeutics (PDTs). This role requires someone with regulatory knowledge and experience with class II medical devices and software as a medical device (SaMD) products.  Software systems and Quality experience is a big plus. This role is a combination of both leadership, strategic and execution responsibilities and requires someone who is skilled at strategy development, interactions with Regulatory Agencies as well as writing and filing of pre submission documents, 510(k)s / De Novo/ PMAs, and periodic reporting.

Summary Of Key Responsibilities

Health Authority Interactions and Regulatory Intelligence

Regulatory Strategy, Submissions and Approvals 

Regulatory support of Product Development 

Qualifications and Skills

Education and/or Experience 

Computer Skills                   

Knowledge of business software applications, internet capabilities, 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.

Flexible regarding location and remote work

To apply, please send your resume to us at jobs@bluenotetx.com. Talk to you soon!