Travel Requirements: This position requires up to 25% travel.
Application Period: November 15, 2022 – December 15, 2022
Salary: Salary starts at $126,233 and is commensurate with qualifications/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.
Introduction: The Center for Devices and Radiological Health (CDRH), a major regulatory component of the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS), is inviting applications for a Regulatory Policy Analyst in the Office of Policy (OP). OP provides leadership for all policy-related activities at CDRH.
Position Summary: Reporting directly to the Associate Director of Guidance, Legislation and Special Projects, you will primarily be responsible for: drafting guidance documents and other policy documents, and collaborative policy development within CDRH, specifically for medical devices and radiological health products; leading work groups to accomplish these responsibilities and objectives; coordinating with other FDA Centers and Offices; analyzing public comments on guidance documents and implementing appropriate revisions; and providing regulatory/policy support regarding the policies and procedures relevant to the development and issuance of CDRH guidance documents.
Duties/Responsibilities: As a Regulatory Policy Analyst you will also:
Write and critically review documents related to CDRH policy and program proposals, focused on guidance documents and other policy documents (e.g., discussion papers of public health importance).
Develop, in collaboration with other CDRH offices and divisions and in accordance with CDRH Guiding Principles, policies and programs involving complex, high-priority, and cross-cutting matters affecting medical devices and radiological health products.
Apply regulatory knowledge and policy development skills to draft, revise and consolidate comments and discussion in the efficient development of complex guidance and/or cross-cutting policies that impact multiple CDRH or FDA components.
Lead cross-Center or cross-Agency working groups to develop complex guidance documents and/or cross-cutting policies.
Effectively brief and engage Senior management to seek input and discuss areas of unresolved policy matters and cogently integrate concepts into guidance documents, considering the applicable laws and relevant regulatory framework.
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:
Expertise in medical device law, including but not limited to, the Federal Food, Drug, and Cosmetic (FD&C) Act, the Public Health Service Act, the Medical Device User Fees Amendments and subsequent amendments, etc.
Expert knowledge of FDA’s regulatory and statutory framework to advise leadership of the impact on an organization or industry.
Ability to analyze and evaluate policy/guidance and determine appropriate approaches regarding the regulation of devices.
Utilizing regulatory knowledge to draft, revise and consolidate complex and technical information in a clear and concise manner for consideration by internal and external stakeholders.
Ability to lead working groups and work effectively and collaboratively within diverse teams as well as prioritize and make critical decisions.
Background Investigation/Security Clearance Requirements: If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant’s successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, if hired, a background security investigation or supplemental investigation may be required later.
Applicants are also advised that all information concerning qualification is subject to investigation. False representation may be grounds for non-selection and/or appropriate disciplinary action.
Vaccination Requirements: To ensure compliance with an applicable preliminary nationwide injunction, which may be supplemented, modified, or vacated, depending on the course of ongoing litigation, the Federal Government will take no action to implement or enforce the COVID-19 vaccination requirement pursuant to Executive Order 14043 on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees. Therefore, to the extent a federal job announcement includes the requirement that applicants must be fully vaccinated against COVID-19 pursuant to Executive Order 14043, that requirement does not currently apply. Federal agencies may request information regarding the vaccination status of selected applicants for the purposes of implementing other workplace safety protocols, such as protocols related to masking, physical distancing, testing, travel, and quarantine.
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: 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: 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.
The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an agency within the Department of Health and Human Services. The FDA's organization consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy, and Operations. The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.