Deputy Office Director
4 weeks ago
This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. Additional information on 21st Century Cures Act can be found here.Introduction
The Center for Devices and Radiological Health (CDRH or Center), the medical devices regulatory arm of the U.S. Food and Drug Administration (FDA), is now accepting applications for a Deputy Office Director position in the Office of Neurological and Physical Medicine Devices/ Office of Health Technology V (OHT5 or Office).Duties/Responsibilities
- Serve as the technical authority and principal advisor to the Office Director on the total product lifecycle of in-scope devices, to include premarket evaluations, compliance and quality, and surveillance programs.
- Develop and cultivate strategic relationships with key internal and external stakeholders, such as the medical device industry, trade associations, other Federal agencies, other countries, state agencies, and the general public.
- Oversee 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.
- Oversee medical and healthcare compliance activities including inspections, classifications, recall classifications, labeling reviews, import alerts, as well as custom device reports and surveillance activities including MDR reviews and analyses, 522 Studies, and PAS studies.
- Develop and implement policies and procedures in relation to Office and Center goals that align with federal budgetary and economic realities.
Supervisory Responsibilities: You will manage and grow high-performing multidisciplinary scientific, technical, and professional staff in support of advancing the public health mission, strategic goals, and vision of the Office. You will monitor and evaluate the technical performance of Office and Division staff who serve as experts in their respective fields. You will mentor, coach, advise, and identify training needs and professional growth opportunities for Office staff to support and advance productivity and work product quality.
QualificationsTo be placed into a Cures position, candidates must meet the following criteria:
- Scientific, Technical, and Professional Fields
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:
Manage a multi-disciplinary staff responsible for scientific, public health and/or regulatory activities associated with food, drugs and/or devices.Evaluate policies and determine appropriate approaches regarding the regulation of food, drugs, and/or devices.Lead the strategic achievement of organizational goals, evaluating organizational performance and taking action to improve performance.Desired Professional Experience and Education: Our ideal candidate will possess the following experience:
Skilled in identifying problems, gathering information, drawing conclusions, and proving effective recommendations.Ability to prioritize and make critical decisions.Advanced degrees in applied, life, and/or physical sciences, such as Biology, Microbiology, Engineering, Physics, or medical fields are highly desired.How to ApplySubmit resume or curriculum vitae and transcripts (unofficial), 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). Please include the following Job Reference ID in the subject line of your email submission: Deputy Office Director (OHT5/IO) – Last Name, First Name
FOREIGN EDUCATION: You must show that your education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs. 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, 1959One-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 RequirementsBackground 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: FDA Ethics.Equal Employment Opportunity
Equal Employment Opportunity (EEO) for federal employees & job applicants
The FDA is an equal opportunity employer with a smoke free environment.
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