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
- Lead regulatory agency interactions in partnership with appropriate technical experts
- Monitor changes in the SaMD/PDT regulatory environment, both general and specific to the Oncology therapeutic area and support and advise the project team(s) accordingly
- Monitor and influence the new PDT regulatory space by representing the company on industry teams and FDA guidance development working groups as identified
Regulatory Strategy, Submissions and Approvals
- Lead the development of regulatory interactions, filing and lifecycle strategies for current and future portfolio of PDTs
- Develop and lead the regulatory submission planning, development and filing process
- Proactively address issues, gaps, options, and trade-offs for the project plan to increase the probability of an optimal and timely submission and approval
Regulatory support of Product Development
- Serves as the point of contact and regulatory representative on the Product Team(s).
- Provide expertise on medical device software products SaMD in support of Design History File (DHF) development and requirements for Design Controls
- Assess regulatory impact of changes to the product
- Perform regulatory review of promotional materials
- Ensure consistency, quality, completeness, and adherence to FDA standards and expectations for all regulatory submissions
- Provide regulatory risk and compliance assessments concerning the company’s products and strategic planning
- Support due diligence activities
Qualifications and Skills
- Expertise in US and OUS medical device regulations and standards including ISO 13485, 14971, and 21 CFR 820, 11, 210, 211, as well as applicable regulatory guidance
- Experience in leading the development and filing of regulatory documents to CDRH for marketing authorization (eg. 510k, DeNovo, PMA), support and Q-submissions and periodic reporting (including MDRs)
- Detail oriented and strong technical writing skills
- Strong team player with demonstrated success in leading and working on cross-functional teams in fast-moving environments
- Strong interpersonal, communication (verbal and written), organizational and project management skills (including proficiency in Word, Excel, and PowerPoint)
- Familiarity with software development, including Agile or related methodologies
- Familiarity with GCP (Good Clinical Practice) and GMP (Good Manufacturing Practice) regulations and guidance
- TRAVEL: Ability to travel up to 30% of the time as needed
- The statements herein describe the general nature and level of work being performed by employees assigned to this position and should not be construed as an exhaustive list of all responsibilities, duties, and skills required or assigned
Education and/or Experience
- Bachelor of Science degree in Life Science, or comparable industry experience required/ Master’s degree preferred
- 5-7 + years’ regulatory strategy and document creation experience in medical device development and lifecycle management of SaMD or relevant surrogate
- Experience with QMS (Quality Management Systems), DHF (Design History Files), Complaint handling and QSIT inspections
- Experience interfacing with Internal Review Boards (IRBs) a plus
- Proven leadership and program management experience
- Ability to think strategically and critically
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 firstname.lastname@example.org. Talk to you soon!