Travel Requirements: This position requires up to 25% travel.
Application Period: Wednesday, October 6, 2021 through Friday, November 5, 2021
Salary: The starting salary for these positions is $122,530 based on candidate qualifications and is set 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.
Introduction: The Center for Devices and Radiological Health (CDRH or Center) assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.
Within CDRH, the Office of Policy (OP) provides leadership for all policy-related activities, including oversight and leadership in the development of regulations, guidances, policies, and procedures concerning medical device and radiation-emitting products under the Federal Food, Drug, and Cosmetic Act. Additionally, the Office provides leadership and expertise in the planning and implementation of proposals for new regulations and policy statements. OP also provides leadership on legislative activities, such as the development and evaluation of legislation, responses to Congressional inquiries, and briefings for Congressional members and their staff.
As a Regulatory Counsel, you will serve as a recognized regulatory expert in the applicable statute and regulations, as well as the policies and procedures relevant to the issuance of FDA regulations and policy documents, particularly for medical devices and radiation-emitting products. You will work with administrative, scientific, and professional staff throughout CDRH on a variety of policy assignments and will be recognized as the authority within the Center on ensuring that the work is accurate, thorough, and consistent with statutory or regulatory requirements and that their need is justified. You will provide expert policy and regulatory consultation, problem identification, and resolution of complex legal issues. Additionally, you will identify key legal or policy issues and priorities, drafts legal analyses, evaluate alternative strategies, and make definitive recommendations to senior management.
As a Regulatory Policy Analyst, you will draft guidance and policy documents and collaborate with Office and Center leadership in the development of policy, specifically for medical devices, diagnostic equipment, and radiological health products. You will also lead work groups, coordinate and engage with colleagues from other Centers and Offices within the Food and Drug Administration to leverage expertise to accomplish these objectives and responsibilities of the Office. Further, you will analyze public comments on guidance documents and implement appropriate revisions and provide regulatory/policy support regarding the policies and procedures relevant to the development and issuance of CDRH guidance documents.
As a Regulatory Counsel in OP, the candidate will:
Provide regulatory advice and counsel to others, including senior management, such as the Center Director, Office Director, Deputy and Associate Office Directors, other Regulatory Counsels, Consumer Safety Officers, and others as necessary, both within the Office of Policy as well as other Offices, within CDRH.
Review proposed compliance and enforcement activities, which may include warning letters, legal actions (i.e., seizures, injunctions), or administrative enforcement actions (e.g., administrative detention orders, mandatory recall orders) recommended by the Offices to ensure sufficient evidentiary support, consistent with Center and Agency policy, and that is legally supportable to take action.
Conduct analyses to consider impacts of new or evolving legislation on the Center/Office medical device programs.
Prepare Center responses on issues that are industry-wide in scope, have broad health implications, and that concern precedent-setting interpretations of FDA policy.
Review and comments on the Center’s safety-related communications to patients, healthcare providers, industry and other stakeholders.
Writes and establishes policies and procedures that ensure the sufficiency and procedural adequacy of regulatory documents and policy statements and initiatives.
In developing regulations, correspondence, and other written statements of Agency policy, the incumbent consults with staff at all levels of the Agency, including the Commissioner’s Office, to identify areas of disagreement with the Center or between the Center and other units of FDA and assists his or her Office management in resolving such disagreements and articulating consensus reached through this process.
Serve as a Center representative in delegated discussions or Working Groups with the Office of the Commissioner and the Office of Chief Counsel concerning regulatory and enforcement policies associated with medical devices, including discussions concerning consistency in enforcement actions and remedies.
Identify and assesses emerging, current, complex, or precedent-setting issues that impact the Office's procedures and policies related to the regulatory oversight of medical devices, with a particular emphasis on compliance-related activities.
Review citizen petition responses which may raise issues that have an industry-wide effect or high interest in the community. Develops a course of action and drafts, or coordinates the drafting of, responses to such cross-cutting petitions.
As a Regulatory Policy Analyst in OP, the candidate will:
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.
Use 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.
Effectively 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.
Provide advice on the potential impact of final guidance or policy documents on training needs (for internal and/or external stakeholders) as well as other considerations for effective implementation of the policies.
Interpret and analyze existing policies and precedents that affect internal and industry program activities and the marketing of regulated products in which CDRH has jurisdiction.
Serve as an organizational expert in analyzing the impact of existing or proposed legislation on FDA policies reflected in guidances.
Analytically review public comments received on draft guidance to efficiently and effectively finalize guidance in collaboration with critical stakeholders.
Periodically ascertain whether guidance documents still represent current CDRH policy and, as appropriate, develop timely plans to update or sunset guidance documents; and
Provide input in the establishment of annual guidance lists (Fiscal Year A/B lists), including stakeholder engagement to inform these activities.
Professional Experience/Key Requirements:
To meet qualification requirements, the applicant’s work experience must have demonstrated the knowledge, skills, and abilities, and competencies necessary to perform at the level of the position. Qualifying experience involves knowledge of federal regulatory programs.
To qualify, you must possess technical experience and expertise including:
Knowledge of medical device law, including but not limited to, the Federal Food, Drug, and Cosmetic (FD&C) Act, the Public Health Service Act, Small Business Regulatory Fairness Act, the Paperwork Reduction Act, the Medical Device User Fees Act and subsequent amendments, 21st Century Cures, CARES Act, etc. Regulations include, but are not limited to, Title 21 of the Code of Federal Regulations
Application of FDA’s regulatory and statutory framework to advise management of the impact on an organization or industry.
Analyzing and evaluating policy/guidance and determining appropriate approaches regarding the regulation of medical 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.
Significant knowledge of regulatory practice, policies, and procedures, with experience related to the regulation of medical devices.
Experience making recommendations regarding the application of the statutory or regulatory framework of the FD&C Act, specifically for medical devices.
Excellent written and communication skills.
Ability to work independently and collaboratively with a diverse cadre of customers and stakeholders.
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.
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.
Submit electronic resume or curriculum vitae and letter of interest highlighting applicable qualifications to CDRHRecruitment@fda.hhs.gov with “OP Regulatory Policy Analyst” in the subject line. Applications will be accepted through November 5, 2021.
The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.