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. OHT3 is responsible for the total lifecycle (TPLC) review of reproductive, gastro-renal, urological and general hospital devices. We are also responsible for the CDRH Human Factors program.
As a Physician in OHT3, you will be working on projects involving the full range of medical devices and their accessories used in urological procedures (e.g., peripheral and sacral neurostimulators, surgical mesh for stress urinary incontinence, devices for treatment of voiding dysfunction, prostate cancer treatment devices, etc.). You will review proposed clinical trial protocols to ensure that trials are capable of collecting valid scientific evidence while sufficiently protecting patient safety, analyzing the results of clinical trials to determine whether they support the safety and effectiveness of a given product, development of scientifically sound clinical review policy for urological devices, evaluation of post market device safety issues/recalls and outreach to device manufacturers and physician groups on clinical topics.
The Physician also performs the following duties:
• Review total product life-cycle actions (premarket, compliance, and post-market surveillance) related to urological devices. Actions may include 510(k), PMA, De Novo, IDE, pre-submission, submission issue request, 513(g), MDRs, recall and complaint submissions.
• Develop, modify, and evaluate guidelines concerning clinical data required in medical device actions to be submitted to the Agency. In this capacity, the incumbent participates as a member of a team of experts to develop agency- or center-wide guidelines applicable to the regulation of relevant medical devices.
• Present reviews, conclusions, opinions, and recommendations to outside stakeholders on submissions and review issues. These discussions will include key issues pertaining to the safety and effectiveness of the medical device(s), outlines of deficiencies, and recommendations for approval or non-approval of the device or the submission.
• Enhance professional career development by collaborating with engineers, clinicians, and scientists to better understand medical device problems. Keep abreast of current events and findings and changes in medical device law and regulations through review of scientific and legislative literature, personal contact with relevant authorities, and by attending scientific meetings.
PROEFESSIONAL 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:
• Expertise in urinary incontinence (e.g., surgical mesh, neurostimulators) and female pelvic medicine and reconstructive surgery is highly desired.
• Collaborating with 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 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.
• Knowledge of the regulatory total product lifecycle (TPLC) review process of reproductive, gynecology and urology devices including: 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.).
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