Regulatory Affairs Advisor (Part Time)

About Sepsis Alliance:

Sepsis Alliance, the first and leading sepsis organization in the U.S., seeks to save lives and reduce suffering by improving sepsis awareness and care. More than 1.7 million people are diagnosed with sepsis each year in the U.S. with more than 270,000 dying and over 50% of survivors experiencing post-sepsis syndrome and other lingering effects, including amputations. At Sepsis Alliance’s founding in 2003, only 19% of U.S. adults were aware of the term “sepsis.” After over ten years of educational efforts for the general public and healthcare providers through Sepsis.org, Sepsis Alliance Clinical Community, Sepsis Alliance Institute, and Sepsis Alliance Voices, awareness is at 65% with over 30,000 healthcare providers across the country having attended sepsis webinars and courses to elevate their practice and over 28 Sepsis Awareness Month state proclamations. Sepsis Alliance is a 501(c)3 nonprofit and a GuideStar Platinum Rated charity. For more information, please visit www.sepsis.org and connect with Sepsis Alliance on Facebook, Twitter, Instagram, and LinkedIn at @SepsisAlliance.

About Sepsis:

Sepsis is the body’s overwhelming response to infection, which can lead to tissue damage, organ failure, amputations, and death. Sepsis is the #1 cause of death in U.S. hospitals, killing 270,000 people each year in the U.S., or one person every two minutes. Sepsis kills more children than cancer and more adults than breast cancer, prostate cancer, and opioid overdoses, combined. It is the #1 cost for acute and skilled nursing care at $62 billion per year. Sepsis is the most severe complication of COVID-19 that is responsible for most deaths from this infection.

In the United States, differences in health and mortality are influenced by both socio-economic status and race/ethnicity. Black and “other nonwhite” individuals have nearly twice the incidence of sepsis as whites. Black people bear nearly twice the burden of sepsis deaths relative to the size of the Black population, as compared to white people, and sepsis deaths among American Indians/Alaskan Natives and Hispanics are also elevated as compared to white people. For Sepsis Alliance, health equity means eliminating preventable disparities in sepsis awareness, incidence, morbidity, and mortality.

Position Overview:

Sepsis Alliance has a cooperative agreement with the U.S. Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response (ASPR) to support the Biomedical Advanced Research and Development Authority’s (BARDA) Solving Sepsis Initiative by establishing Infection Management/Sepsis Collaborative Community (IMSCC), a continuing forum in which private- and public-sector stakeholders work together on medical device challenges to accelerate innovation in sepsis-related devices and technology. We are seeking a Regulatory Affairs Advisor who wants to do something meaningful and lasting to improve the development process for medical devices and health technologies that will save lives and, in time, solve sepsis. This position provides a unique opportunity to shape the medical device and health technology process and have a long-term impact on the sepsis ecosystem. The Regulatory Affairs Advisor will have a significant role in driving regulatory policy initiative, writing or contributing to the writing of publications and analyses, and working with FDA to improve regulatory policy.

Role:

The Regulatory Affairs Advisor is responsible for managing regulatory matters for IMSCC. Working closely with the IMSCC project team, volunteer-led workgroups, and IMSCC members, the Regulatory Affairs Advisor will help to define, manage, and execute plans to improve regulatory processes to accelerate FDA clearance and adoption of infection severity diagnostic tools (ISDTs), including development of regulatory science and policy and assisting with the implementation of such policy improvements by providing input and expertise to complement the knowledge of the project team and IMSCC. ISDTs utilize host biomarkers, clinical data, electronic health record-based algorithms, or a combination of those to enable patient assessment at different points along the infection severity continuum and have the potential to determine whether infections are viral, bacterial, or fungal based on host response characteristics and stratify patients’ risk for progression to sepsis regardless of infection type. The Regulatory Affairs Advisor will support projects to address systemic barriers to acceptance, adoption, and implementation, including but not limited to: improving stakeholder-wide understanding of unmet needs of sepsis patient/survivors and opportunities to engage them throughout the total product life cycle of ISDTs; identify regulatory barriers and opportunities to accelerate development and clearance of ISDTs; and identify issues and opportunities to improve clinical trials of ISDTs.

Duties and Responsibilities:

• Provide subject matter expertise on all regulatory matters related to assigned projects; ensure IMSCC project team, volunteer workgroups, and IMSCC members are kept current on the progress of projects through regular reports.
• Provide regulatory support to IMSCC project team, volunteer-led workgroups, and IMSCC members, which includes advising on any FDA and/or CMS-related activities and issues and attending meetings as appropriate.
• Provide input and direction regarding FDA, CMS, and other regulatory policies related to infection management and sepsis innovation; work collaboratively with internal and external stakeholders, including patient organizations, researchers, industry, and government agencies.
• Lead the development of a regulatory strategy that fosters innovation and the approval/licensure/clearance of novel medical devices.
• Prepare reports, white papers, position papers, presentations, comments, proposals, strategies, and impact statements for internal and external audiences, in collaboration with the IMSCC project team, volunteer-led workgroups, and IMSCC members, as needed.
• Monitor and analyze regulatory developments related to IMSCC objectives.
• Provide regulatory guidance/consultation to external stakeholders as needed.
• Provide regulatory guidance and/or training to project team, volunteer-led workgroups, and IMSCC members as needed.
• Facilitate discussion and consensus building.

Qualifications:

• Thorough knowledge of laws and FDA regulations related to medical devices required.
• 5 or more years of direct regulatory affairs experience required, medical device industry experience highly preferred.
• Project management experience highly preferred.
• Experience working and communicating with FDA highly preferred.
• Bachelor’s degree required, Master’s in regulatory affairs preferred.
• Regulatory Affairs Certification (RAC) preferred.
• Helpful to have experience working with volunteers.
• Helpful to have experience in clinical trial design.
• Helpful to have experience in data reporting and working with datasets.

Skills:

• Ability to read, analyze, and interpret scientific, technical data, and regulatory guidelines and regulations.
• Demonstrate critical thinking, risk assessment, and judgment.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to work as part of a team and independently.
• Excellent verbal and written communication skills.
• Excellent organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously.
• Expert in MS Office.

Schedule & Location: This a remote part-time position (20 hours/week) with infrequent travel to the Washington, DC area possible. Please note that this is a 7-month contracted position with the possibility to extend.

Sepsis Alliance is committed to developing and implementing programs and initiatives to promote diversity and inclusion in all areas of employment. As part of this commitment, applicants are given the opportunity to answer equal opportunity employment questions. This protected information will only be used to evaluate our recruitment efforts through standard reporting, and will not be shared with hiring managers or other team members. Every applicant has the option not to disclose this information.