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. OHT6 is responsible for the total product lifecycle (TPLC) review of orthopedic devices.
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Reporting directly to the Office Director, Office Deputy Director leads, manages, and sets strategy for Office of Health Technology-6 (OHT6) and serves as the technical authority and principal advisor to the Office Director on scientific and technical
topics within OHT6. Serves as the Acting Director in the Office Director’s absence. The incumbent ensures OHT6 activities are aligned to the goals and priorities of OPEQ. Ensures OHT6 advances the Center’s mission and vision. Implements the Center and
OPEQ’s Strategic Priorities. Develops and implements policies and plans that are sound and feasible in relation to OPEQ and Center goals and federal budgetary and economic realities.
The Office Deputy Director leads, manages, and sets strategy for OHT6 staff and serves as the technical authority and principal advisor to the OHT6 and OPEQ Directors on scientific and technical topics within OHT6. The incumbent ensures OHT6 activities are aligned to the goals and priorities of OPEQ. Provides technical, policy and administrative leadership and direction to the subordinate staff of the Office through subordinate supervisors and exercises the full range of first and second‐level supervisory responsibilities.
Exercises significant responsibilities in dealing with officials of other units or organizations, or in advising management officials of higher rank.
With the Office Director, the incumbent has responsibility for the development, establishment, and clearance of goals, objectives, and strategic plans for the Office; manages the overall work of the Office to enable achievement of the goals and objectives; oversees the revision of long range plans, goals and objectives of the Office; manages the development of program and policy changes in response to the needs of the FDA‐CDRH and revisions to Federal and Departmental laws, regulations, and requirements; manages organizational changes within the Office, including proposals to achieve maximum effectiveness and efficiency; and develops the Office’s annual budget request.
The Deputy Office Director:
· Shares with the director the responsibilities of leading, managing, and setting strategy for OHT6 and serves as the technical authority and principal advisor to the Office Director on scientific and technical topics within OHT6.
· Serves as the Acting Director in the Office Director’s absence. The incumbent ensures OHT6 activities are aligned to the goals and priorities of OPEQ.
· Directs the OHT6 program management operations for regulating safety and effectiveness of all general orthopedic medical devices, marketed in and utilized throughout the United States.
· Provides technical and scientific leadership and guidance in review of policy and procedures associated with orthopedic devices.
· Serves as the Office focal point and primary contact for medical device regulatory and scientific issues and provide expert and authoritative advice, guidance, assistance, interpretations, consultations and recommendations to top level and senior Agency and Departmental officials, program directors, scientific and professional personnel, industry representatives, intra/inter-governmental counterparts and others concerning medical device policies, programs and activities.
· Advises and informs the OHT6 Director and other key agency officials on activities resources and related considerations which may affect or impact upon the planning, development and administration of device evaluation and other Office and/or Center program.
· Represents the Office, Center Director and FDA (when necessary), and participates as the Office’s scientific and regulatory authority, on all matters related to medical device regulatory issues in conferences, meetings and discussions with top level Agency and Departmental officials, regulated industry representatives, the medical scientific and academic Communities, national and international scientific and health related professional organizations, representatives from foreign governments, etc.
· Report to Office Director, OHT6 Programs and performs other duties as assigned.
Professional Experience/Key Requirements:
To qualify for this position, you must possess technical experience including:
• Knowledge of organizational, operational, and programmatic concepts and practices applied by public, private, or nonprofit standard development and regulatory agencies and/or organizations engaged in public health or other health-related areas of manufacturing standards development;
• Skillful in effectively interpreting and presenting complex scientific, technical, and regulatory information and concepts, in both written and oral formats for a variety of audiences.;
• Ability to build collaborative and mutually beneficial working relationships with a diverse cadre of customers and stakeholders;
• Knowledge of the regulatory total product lifecycle (TPLC) review process (pre- and/or postmarket) of orthopedic devices;
• Applicants with an advanced degree in science, engineering, or medical fields are highly desired.
Candidates must possess the required individual occupational requirements to qualify for the appropriate series applicable to the position. Please use the following link to determine the series for which you qualify: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/#url=List-by-Occupational-Series
Conditions of Employment:
· One-year probationary period may be required.
· Background and/or Security investigation required.
· U.S. citizenship is required.
· All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. Visit www.SSS.gov for more info.
· 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 containing a brief summary of scientific accomplishments, and copy of transcripts
· Compile all applicant documents into one combined document (i.e. Adobe PDF)
· Include Job Reference code “OHT6 Deputy Director” in the email subject line.
· Email comprehensive applicant package/document to CDRHRecruitment@fda.hhs.gov by Monday May 10, 2021.
The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer.