Travel Requirements: This position may require up to 25% travel.
Application Period: Monday, August 16, 2021 through Thursday, September 30, 2021
Salary: Salary starts at $163,962.00 and is commensurate with education and experience
Conditions of Employment: United States Citizenship is required.
Special Notes: This position is being filled under an excepted 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 the authority. Additional information on 21st Century Cures Act can be found here.
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. OHT7 is responsible for the in vitro diagnostic, radiological health, and mammography quality standards programs.
To learn more about the exciting work taking place at CDRH, we invite you to watch and listen as one our scientists shares his passion for the work he does, the Center and Agency's innovative and pioneering approach to regulatory science, CDRH’s diverse, inclusive, and nurturing culture, professional growth opportunities, our direct impact on public health, and why he loves working at the FDA, by clicking here.
CDRH is seeking an experienced, dynamic, and innovative scientific and regulatory professional to serve as the Deputy Office Director of OHT 7. In this position, reporting directly to the OHT VII Office Director, you will have the opportunity to universally impact and improve the health outcomes and the quality of life of the American people through the advancement of diagnostic medical products. You will be responsible for providing leadership, administrative management, and exercising sound scientific, clinical, and evidenced-based technical judgement in the review of in scope medical products throughout their lifecycle. You will advance the Office’s strategic vision, core business objectives, long-range and short-term projects, and develop OHT VII’s annual budget allocation request.
You will assist the OHT VII Office Director in setting strategy, advancing initiatives, and ensuring the goals, priorities, and objectives of the Office align with those of OPEQ, the Center, and the Agency. As a creative and collaborative leader, you will assist in managing and growing a high-performing, multidisciplinary scientific, technical, and professional team, for optimal efficiency and performance, in support of advancing the strategic vision of the Office. As such, you will evaluate the technical and managerial performance of your subordinate supervisors and devote at least 25 percent of your time towards coaching, mentoring, and supervising your leadership team. Further, you will develop, establish, and advance Office policies, procedures, and protocols that are sound, effective, and feasible in relation to Center goals and federal budgetary and economic realities.
As the Deputy Office Director, you will perform the following:
Utilize expert scientific and technical knowledge and vast regulatory expertise to serve as an authoritative and principal advisor to the OHT VII Office Director, as well as the OPEQ and Center Directors on matters involving in vitro diagnostic medical products, both novel and existing, encompassing the entire product lifecycle.
Provide expert consultation to the OHT VII and OPEQ Office Directors on programmatic plans, health care community, scientific, supply chain, and industry related trends, significant concerns and adverse event data regarding diagnostic medical products regulated within the Office.
Advises and informs the OHT VII Office Director, the Center Director, and other key Agency officials on activities, resources, and related considerations which may impact the planning, development, and administration of patient safety and product quality programs.
Serves as the Office focal point and primary expert in patient safety and product quality, providing information and consulting with individuals, federal agencies, private medical device industry, universities, and/or foreign governments on consumer safety and patient safety issues
In concert with the OHT VII Office Director, develop, coordinate, and establish Office-wide policies, procedures, and programmatic norms rooted in science to assure medical products, especially those novel in nature and with emerging technologies, within scope are safe, effective, reliable, and available for patients and providers.
Ensures the uniform adoption, implementation, and consistent application of OPEQ and OHT VII-wide guidance, initiatives, and policies regarding the regulatory oversight of medical products within the scope of the Office are followed.
Partners with Division leadership to ensure the uniformed high quality and consistency of scientific and regulatory reviews across the total product lifecycle of medical products within scope of the Office.
Supports review staff by leveraging the necessary expertise on pre-market, compliance, and surveillance, as well as clinical, scientific, and regulatory policy expertise for reviews.
Provides technical and scientific leadership and guidance in review of policy and procedures associated with the regulated medical device industry in patient safety and product quality.
Represents the Office, Center Director and FDA (when necessary), and participates as the Office's scientific and regulatory authority, on all matters related to regulated medical device industry in patient safety in conferences, meetings and discussions with top level government officials, regulated industry representatives, the medical scientific and academic communities, national and international scientific and health related professional organizations, representatives from foreign governments, etc.
Ensures the comprehensive support of product advisory panels, industry, and consultants and coordinates actions on classification actions, petitions, premarket notifications (510(k)s), premarket approval applications (PMAs), PDPs, De Novos, 513(g)s, and Investigational Device Exemptions (IDEs) with Center and Agency components or other organizations, when appropriate.
Collaborates with Division leadership to plan, organize, and establish or realign priorities, assignments, and work projects to advance new initiatives and/or the programmatic and regulatory objectives of the Division and Office
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:
Manage and lead a multidisciplinary staff responsible for scientific, regulatory, and/or public health activities associated with FDA regulated medical products.
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.
Analyze, interpret, and share regulatory policy on scientific matters that may be highly complex, precedent setting, or controversial in nature.
Applicants with advanced degrees in science, engineering, or medical fields are highly desired.
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:
Submit electronic resume or curriculum vitae, cover letter containing a brief summary of scientific accomplishments, SF-50 (if applicable), and a copy of unofficial transcripts all in one document (Adobe PDF) to CDRHRecruitment@fda.hhs.gov with Job Reference code “2020-OHT7-IO-M4-P-147” in the subject line. Applications will be accepted through September 30, 2021.
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.
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.