Regulatory Affairs, Digital Diagnostics Leader - Remote

Company: Danaher Corporation
Location: Raleigh
Posted on: April 8, 2021

Job Description:

Danaher Corporation Regulatory Affairs, Digital Diagnostics Leader - Remote in Raleigh , North Carolina Wondering what's within Beckman Coulter? Take a closer look. Join a team where you can be heard, be supported, and always be yourself. At Beckman Coulter, a Danaher company, we're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. We are dedicated to advancing and optimizing the laboratory to move science and health care forward for more than 80 years. Find the opportunity to build relevant career, be creative, and try new things with the support needed to be successful. Find the Danaher Business System, which makes everything possible. At Beckman Coulter, at the heart of what we do, witness our shared purpose-helping realize life's potential-in action. We hope you'll see yourself here, since this position can be based Remote. What you find at Beckman Coulter -and within yourself - might just change the world! Beckman Coulter has partnered with the Biomedical Advanced Research and Development Authority (BARDA), under the Office of the Assistant Secretary for Preparedness and Response (ASPR), within the United States Department of Health and Human Services (HHS) to develop a machine learning algorithm that predicts sepsis, including SARS-CoV-2 viral-induced sepsis resulting from the COVID-19 pandemic. The Beckman Coulter sepsis solution is the first of a portfolio of digital diagnostics solutions to drive clinical insights from medical records and Danaher operating company (including Beckman Coulter) laboratory instrument data. Reporting to the Vice President of Quality, Regulatory, and Clinical Affairs, the Digital Diagnostics Leader, Regulatory Affairs, will have the primary responsibility of leading the sepsis BARDA core team through a Software as a Medical Device (SaMD) regulatory submission process, preparing the regulatory submissions and interacting with the FDA. In this leadership role, you will help shape an innovative digital diagnostics regulatory strategy for new digital diagnostic (Dx) products that use machine learning and AI technology to improve clinical outcomes. You will also work closely with clinical affairs to drive novel regulatory submissions for claims expansions on existing products using real-world evidence (RWE) as part of the regulatory data submission packages. We are looking for a passionate and ambitious leader to join us in this cutting-edge digital healthcare transformation journey; someone who is driven by our strong sense of purpose to improve patient outcomes. Beckman Coulter is seeking a candidate who is comfortable working in a dynamic fast-paced environment with a strong sense of urgency and proven ability to be flexible and adaptable. This position is Remote with up to 25% travel when possible in the future. This role also includes the following opportunity to: Owner of regulatory timelines and management of regulatory submissions and compliance for our Digital Dx solutions, beginning with the Sepsis BARDA SaMD program. Regulatory oversight, including leading all communications and submissions with regulatory agencies, continues for entire product development life cycle, including post-market surveillance Future regulatory submissions may include expansion of claims to existing products where regulatory submission is based off of real-world evidence data submissions; be prepared to navigate such ambitions in collaboration with clinical affairs leaders Own execution of sound US digital health regulatory strategy for the company's medical devices involving use of SaMD, Artificial Intelligence, and Machine Learning to achieve clearances/approvals in alignment with business priorities Maintain a strong grasp of regulatory guidance and trends, ensuring that information is disseminated across the organization for effective decision making; may involve executive education to ensure senior leaders in Danaher have a good understanding of the Digital Dx regulatory landscape Guide leadership in deciding when algorithm use cases on the product roadmap should undergo a SaMD path versus a non-regulated clinical decision support (CDS) pathway The essential requirements of the job include: A Bachelor's degree with 14 years of experience in Regulatory Affairs activities 10 or more years of healthcare or IT regulated industry experience is preferred with prior responsibility for regulatory affairs activities Subject Matter Expert in pre- and post-market medical device regulations, requirements and submissions, especially De Novo submissions, PMA, 510(k), and 21CFR820.30. Familiarity with ISO 62304 and IEC/ISO 62304 medical device software life cycle process also desired Sound knowledge of SaMD US FDA digital health regulations and requirements, legislation, industry standards and guidance It would be a plus if you also possess: Advanced degree in biological, biomedical, or data science/software Experience working in the acute care healthcare space Awareness of global digital health regulations and requirements Beckman Coulter, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to associates' lives. Whether it's a health care program or paid time off, our programs enhance life beyond the job. Check out our benefits at danaherbenefitsinfo.com. Work hard and with guidance from committed leaders, powerful DBS tools, and the support of a global organization. As part of Danaher's 67,000 associates across the globe, the possibilities for growth and development are unparalleled. We believe that creativity and innovation thrive when the most diverse set of voices are heard, and that's why we're taking concrete steps to ensure that we're fostering an inclusive and engaging workplace. To learn more, read about our associates on our Careers Blog or contact one of our recruiters. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here.

Keywords: Danaher Corporation, Raleigh , Regulatory Affairs, Digital Diagnostics Leader - Remote, Other , Raleigh, North Carolina