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This is a DIRECT HIRE Position

The Center for Devices and Radiological Health (CDRH) is a department of the Food and Drug Administration (FDA) responsible for protecting and promoting the public health. They assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.

The FDA, CDRH is seeking a seasoned and innovative digital health leader to serve as Division Director of a Division of Digital Health (DDH) and for the Digital Health Center of Excellence (DHCoE) in the Office of Strategic Partnerships and Technology Innovation (OST), Center for Devices and Radiological Health (CDRH).  OST represents the Center and collaborates with a broad and diverse array of national and international entities including other government agencies, Congress, industry, academia, consumer and patient organizations, and healthcare professional organizations, with mutual interests in medical devices and radiation-emitting products.

The Division Director serves as leader of a centralized DDH and for the DHCoE, and reports to the Director, OST.  The Division Director addresses cross-cutting digital health issues across the entire organization; providing digital health technical expertise across aspects of a Total Product Life Cycle (TPLC) paradigm;. The Division of Digital Health plays a key role in harmonizing regulation of digital health devices across the world to ensure safe, yet timely access to technology as quickly as possible.  The Division Director is positioned to shape and support digital health technology development across the spectrum of wellness, medical devices, support for clinical trials, and other possibilities.

 

KEY RESPONSIBILITIES:             

In this role, the Division Director advises the Office Director, the Center Director, other intra-agency FDA officials, and external stakeholders on an expansive portfolio of digital health issues.  The Division Director is the Agency lead for Digital Health, shaping cross-cutting policy on how digital health technologies are used and regulated in all medical product-related FDA studies.  Your functions and responsibilities include:

  • Serving as Chair for the FDA’s Digital Health Advisory Board. 
    • The goals of this advisory board are to identify common interest areas and priorities such as research, policies, and other engagements that are most valuable across FDA on the topic of digital health; to coordinate digital health efforts across FDA; and to facilitate and build strategic public and private partnerships with patient and provider communities to advance scientific input to FDA’s oversight.
  • Empowering stakeholders to advance health care
    • BFostering responsible and high-quality digital health innovation;
    • Exercises influence within the direct chain of command, across CDRH, across other FDA Centers, and beyond the Agency in both the public and private sector. 
  • Exploring opportunities to establish premarket approval/clearance pathways tailored to Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and novel digital health technologies that consider real world evidence while incorporating principles established through international harmonization.
  • Supporting internal partners in matters relating to digital health including, but not limited to, health information technology, medical device software, mobile medical applications, interoperability, and cybersecurity. 
    • Aiding in the review of cyber advances affecting the more traditional hardware and software-based medical devices; and coordinating software and digital health expertise and resources within the organization.
  • Exploring and building a new capacity to evaluate third-party certifiers of digital technologies under a precertification program who will play a key role in the efficient development of these products. 
    • The work includes establishing the regulatory paradigm, building new capacity to evaluate and recognize third party certifiers, and supporting a cybersecurity unit to complement the advances in software-based devices.
  • Establishing policies and processes to ensure timely and efficient development, assessment, and review of innovative medical devices and software. The incumbent:
    • Routinely represents the organization at initiatives and meetings with other Federal agencies and international forums
    • Builds coalition with international regulators to develop, coordinate and initiate activities to advance the field of digital health in the global context
    • Provides technological and policy leadership on artificial intelligence and machine learning to position the organization as the global leader to foster safe and responsible creation of machine learning products in healthcare.
  • Developing strategies and programs to building and sustain new technical and scientific expertise to organically grow talent within the organization.
  • This position may require 25-35% travel.


MANAGEMENT DUTIES:

The Division Director provides strategic leadership, supervision, and management in the preparation of work plans, scheduling, and monitoring of project timelines for the DDH and the DHCoE. This includes managing a multi-disciplinary program providing leadership and management oversight to thirty (30) or more subordinate support staff, including approximately seven (7) direct reports. The incumbent provides technical and administrative leadership and direction to the subordinate staff of the Division through subordinate supervisors and exercises the full range of first and second level supervisory responsibilities.  The Division Director will evaluate the technical performance of the team and you will devote at least 25% of your time towards coaching, mentoring, and supervising the team.

 

CANDIDATE QUALIFICATIONS:

Candidates must have professional experience and qualifications commensurate with the duties of the position.  Qualified candidates should possess:

EDUCATION:    

At a minimum, the candidate must possess a Bachelor’s degree in Digital Health, Informatics, Computer Science, Computer Information Systems, Engineering, Business, or a related degree.  Other degrees may be accepted for highly qualified candidates with relevant digital health experience.   Advanced degrees preferred. 

 

Qualifications and Experience:

  • No less than ten (10) years of digital health experience inside the federal government’s public health environment or in the private healthcare sector; international experience is highly desired
  • No less than seven (7) years of leadership experience managing people, teams, and projects, to include planning and assigning work to be accomplished by others; setting and adjusting short-term and long-term priorities; preparing schedules for completion of work with consideration of the difficulty and requirements of assignments, and the capabilities of employees; coaching and mentoring others
  • Demonstrable experience that links digital health to an improved quality of care of patients
  • Skilled in relationship-building, and influencing key leaders and stakeholders, both within and beyond the organization
  • Experience operating in the federal public health space is preferred
  • Ability to work collaboratively with a diverse cadre of colleagues and stakeholders in a continuous quality improvement ecosystem
  • Experience with Medical Device User Fee Amendments (MDUFA) would be beneficial, but not required

 

COMPENSATION:         

An attractive compensation package will be offered based upon background and experience, and commensurate with the FDA guidelines, to include an anticipated annual salary in the range of $175,000 to $250,000 or more, dependent on experience, education, and supporting licenses/credentials.  A one-time recruitment incentive (up to 25%) and an increased leave accrual rate may also be available to candidates.

 

Duty location negotiable upon selection.



You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

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