FDA - Center for Devices and Radiological Health (CDRH) Posted Jun 28, 2021
Silver Spring, MD
DHT4A Division Director (Physician)
The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.
The mission of CDRH is to protect and promote the public health by performing essential public health tasks by making sure that medical devices and radiological health products are safe for people in the United States. OPEQ assures patients have access to high quality, safe and effective products throughout the total product lifecycle by implementing program areas through which medical devices are evaluated or cleared for clinical investigations and marketing. OHT4 is responsible for the TPLC review of surgical and infection control medical devices, to include implementation of premarket review programs (e.g., 510(k), PMA, HDE, DeNovo, IDE, etc.), compliance and quality programs (e.g., Establishment Inspection Report, Regulatory Audit Reports, Recalls, Allegations of Regulatory Misconduct, Labeling, Enforcement Actions, etc.), and surveillance programs (e.g., Medical Device Reports, Post Market Surveillance Studies, Safety Signals, etc.). OHT4 works closely with other offices on classification and reclassification activities, and the development of guidance documents.
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The Division Director, reporting directly to the OHT4 Office Director, partners in providing technical leadership and exercises scientific judgment in general surgery devices. Products areas include electrosurgical devices, minimally invasive surgery devices, light-based energy devices, robotically-assisted surgery devices, microwave, ultrasound, and cryosurgery devices, and point of care diagnostics, among others.
The Division Director, as a supervisor:
• Exercises significant responsibilities in dealing with officials of other units or organizations, or in advising management officials of higher rank.
• Plans work to be accomplished by subordinates, sets and adjusts short-term priorities, and prepares schedules for completion of work; assigns work to subordinates based on priorities, selective consideration of the difficulty and requirements of assignments, and the capabilities of employees.
• Coaches and mentors staff and helps sustain a strong and dynamic culture across teams within the Division, including organizational agility, staff empowerment and mobility, and collaboration.
The Division Director also performs the following duties:
• Serves as a top scientific and technical expert and advisor and is recognized as a national authority and leader in the regulatory lifecycle of medical devices as they relate to the Center’s premarket, compliance and quality programs, and post-market surveillance programs.
• Develops and coordinates a medical device program and implements the program to
assure that the medical devices are safe and effective.
• Provides technical leadership and exercises exceptional scientific and engineering judgment in regulating various medical products.
• Provides technical consultation to the OHT4 Director, OPEQ Director, Center Director, and other high-level officials in the FDA, PHS, and HHS on program status, plans, trends and significant problems relative to the medical device area as called upon and when necessary.
Professional Experience/Key Requirements:
To qualify for this position, you must demonstrate in your resume the necessary qualifying experience for this position, which is equivalent to the following:
• Directing, overseeing, and managing a multi-disciplinary staff responsible for scientific, public health and/or regulatory activities associated with medical products (i.e. devices, biologicals, drugs, etc.);
• Interpreting and assessing scientific data and technical reports to determine the safety and effectiveness of medical products;
• Representing the organization on committees and at professional meetings, and conducting outreach to relevant stakeholder populations; and leading strategic achievement of organizational goals, evaluating performance, and taking action to improve performance.
Physician, GP-0602: Must be a U.S. citizen with Doctor of Medicine (M.D.), Doctor of Osteopathic Medicine (D.O.) or equivalent from a school in the United States or Canada. The degree must have been approved by a recognized accrediting body at the time the degree was obtained.
A Doctor of Medicine or equivalent degree from a foreign medical school that provided education and medical knowledge substantially equivalent to accredited schools in the United States may be demonstrated by the Educational Commission for Foreign Medical Graduates, or a fifth pathway certificate for Americans who completed premedical education in the United States and graduate education in a foreign country. Candidates for Civil Service or U.S. Commissioned Corps must possess a valid license to practice medicine in any state in the U.S. It is highly desired that the prospective candidate has eligible Board Certification.
Licensure: Applicant must possess a current, active, full, and unrestricted license or registration as a Physician from a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.
• Extensive experience in general surgery, and/or a surgical subspecialty; experience with robotically-assisted surgical devices is highly desired
• Extensive experience in and knowledge and management of clinical research, including associated regulations governing clinical research/trials
• Prior scientific and medical expertise on medical devices; professional knowledge and understanding of current FDA regulations, policies, and procedures pertaining to safe and effective medical devices
• Expert skill in written and verbal communications to prepare written documents and findings and to present findings and conduct briefings; expert experience in communicating work to staff at all levels of the organization and varying levels of domain expertise prioritize and make critical decisions.
Additional Conditions of Employment:
• One-year probationary period may be required.
• Background and/or Security investigation required.
• All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption.
• This position is subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for the employee, the spouse, and minor children of the employee. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office website at https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.
How to apply
Prior to applying, please see the following instructions:
• Documents to submit: electronic resume or curriculum vitae, cover letter describing why you are uniquely qualified for this, and copy of transcripts
• Compile all applicant documents into one combined document (i.e. Adobe PDF)
• Include Job Reference code “2021-OHT4-DHT4A-043” in the email subject line.
• Email comprehensive applicant package/document to CDRHRecruitment@fda.hhs.gov by July 28, 2021
Silver Spring, MD 20993
|FDA - Center for Devices and Radiological Health (CDRH)
DHT4A Division Director (Physician)
|Silver Spring, MD|
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