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Deputy Office Director

Employer
FDA Center for Devices and Radiological Health
Location
Silver Spring, Maryland
Salary
Salary is commensurate with education and experience and starts at $181,551.00
Closing date
Jun 1, 2024

View more

Sector
Government
Job Function
Administration
Position Type
Full Time
Level
Any Experience Level Considered

Title 21 Vacancy Announcement

Department of Health and Human Services (HHS)

Food and Drug Administration (FDA)

Center for Devices and Radiological Health (CDRH)

Office of Product Evaluation and Quality (OPEQ)

Office of Health Technology V (OHT5)

 

Application Period: Tuesday, April 30, 2024, through Wednesday, May 29, 2024

Area of Consideration: United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.

Position: Deputy Office Director Series: Biologist (0401); Microbiologist (0403); Physician (0602); General Engineer (0801); Mechanical Engineer (0830); Electrical Engineer (0850); Biomedical Engineer (0858); General Health Scientist (0601)

Location(s): Remote Eligible Salary: Salary is commensurate with education and experience and starts at $181,551.00

Work Schedule: Full-Time                                      

Cures Band(s): Band F                                             Full Performance Band Level: Band F

Travel Requirements: This position requires             Supervisory: Yes      

up to 25% of travel

Bargaining Unit: 8888

This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.  Additional information on 21st Century Cures Act can be found here:

21st Century Cures Act Information

Introduction

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 the Center for Devices and Radiological Health (CDRH or Center) 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.  The Office of Product Evaluation and Quality (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.  The Office of Health Technology V (OHT5 or Office) is responsible for the total product lifecycle (TPLC) review of neurological and physical medicine devices.

Meet one of the faces behind CDRH here.

Duties/Responsibilities

Reporting directly to the OHT5 Office Director, the Deputy Office Director will serve as an assistant to the Office Director and a technical authority on devices regarding safety and effectiveness.  Also, the incumbent provides senior advice and leadership to a scientific, clinical, professional, and technical staff throughout the Office.

 

The Deputy Office Director also performs the following duties:

  • Serves as the technical authority and principal advisor to the Office Director on the total product lifecycle of devices including premarket evaluation, compliance and quality, and surveillance programs.
  • Develops and sustains strategic relationships with internal stakeholders and key external stakeholders such as the medical device industry, trade associations, other Federal agencies, other countries, State agencies, and the general public.
  • Oversees medical device reviews and the decision-making process on classifications, petitions, 510(k)s, HDEs PMAs, PDPs, De Novos, 513(g)s, IDEs, and all supplements and amendments to the submissions.
  • Oversees medical and healthcare compliance activities including inspection, classification, recall classification, labeling review, import alerts, custom device reports and surveillance activities including MDR review and analysis, 522 Studies, PAS studies.
  • Develops and implements policies and plans in relation to the Office, OPEQ and Center goals and federal budgetary and economic realities.
  • Makes assessments, in coordination with the Office Director and evaluates Office operations and strategic priorities.

Supervisory Responsibilities: Direct a multi-disciplinary program, providing leadership and management oversight to subordinate support staff and division directors in the absence of, and in accordance with the Office Director. Plans, assigns, oversees, and directs the work to be accomplished, ensuring timely performance of a satisfactory amount and quality of work; sets and adjusts priorities and timeframes for completion of the work; provides advice and guidance to staff members; reviews work products and accepts, amends or rejects work; develops performance standards and serves as rating official on employee evaluations. Gives advice, counsel, or instruction to employees on both work and administrative matters. Interviews candidates for positions in the Division; recommends appointment, promotion or reassignment of such positions; hears and resolves complaints from employees, referring group grievances and more serious unresolved complaints to a higher-level supervisor or manager; effects minor disciplinary measures, such as warnings and reprimands, recommending other action in more serious cases; identifies developmental and training needs of employees; providing or arranging for needed development and training, finds way to improve productivity or increase the quality of work directed; develops performance standards.

Qualifications

To be placed into a Cures position, candidates must meet the following criteria:

  1. Scientific, Technical, and Professional Fields
  2. Qualified and Outstanding Candidates
    1. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standards as a baseline for comparing experience levels and other candidate attributes for relevant positions.
    2. Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.

In order to qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.

Education Requirement:  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: OPM Occupational Series Qualification Requirements

Professional Experience: To qualify for this position, you must demonstrate in your resume the necessary qualifying experience for this position, which is equivalent to the following:

  • Managing a multi-disciplinary staff responsible for scientific, public health and/or regulatory activities associated with food, drugs and/or devices.
  • Developing and evaluating policy/guidance and determining appropriate approaches regarding the regulation of food, drugs, and/or devices.
  • Leading the strategic achievement of organizational goals, evaluating organizational performance and taking action to improve performance.
  • Ability to build collaborative and mutually beneficial working relationships with a diverse cadre of customers and stakeholders.

Desired Professional Experience and Education: Our ideal candidate will possess the following experience:

  • Excellent leadership and communication skills.
  • Skilled in identifying problems, gathering information, drawing conclusions, and proving effective recommendations.
  • Ability to work collaboratively with a diverse cadre of customers and stakeholders.
  • Ability to build and work effectively within teams.
  • Ability to prioritize and make critical decisions.
  • Applicants with advanced degrees in Biology, Microbiology, General Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, General Health, or related fields.

How to Apply

Submit resume or curriculum vitae and transcripts, with cover letter by Wednesday, May 29, 2024, to CDRHRecruitment@fda.hhs.gov. Compile all applicant documents into one combined document (i.e., Adobe PDF). Candidate resumes may be shared with hiring official within the CDRH with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. Please include the following Job Reference ID in the subject line of your email submission: Deputy Office Director (OHT5/IO) – Last Name, First Name

PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply to this announcement. Officers must follow the instructions for how to apply and include their most recent orders in addition to the required documents. If selected, candidates will be referred to (CC) personnel and not as candidates for a Cures appointment.

Educational Transcripts

SUBMITTING YOUR TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify educational achievement. Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current FDA employee, you are not exempt from transcript requirements.

 

FOREIGN EDUCATION: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.

Conditions of Employment

  • U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
  • Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
  • Applicants must meet all qualification requirements by the closing date of this announcement.
  • Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
  • FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
  • Males born after December 31, 1959 must be registered with the Selective Service.
  • One year supervisory probationary period may be required.
  • Financial Disclosure may be required.
  • Ethics Clearance may be required.
  • Background Investigation/Security Clearance is required. All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.

Security Clearance Requirements

Background Investigation/Security Clearance Requirements: This position requires Public Trust/Moderate Risk security clearance.

Ethics Clearance Requirements

This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.

Equal Employment Opportunity

Equal Employment Opportunity Policy

The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.

Equal Employment Opportunity (EEO) for federal employees & job applicants

Reasonable Accommodation

Reasonable Accommodation Policy

Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job. An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace. An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about disability employment and reasonable accommodations or how to contact an agency.

E-Verify

The Food and Drug Administration participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.

Announcement Contact

For questions regarding this Cures position, please contact CDRHRecruitment@fda.hhs.gov.

 

The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.

 

FDA is an equal opportunity employer.

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