: Regulatory Policy Analyst (CDRH/OP)
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 are safe and effective.
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, guidance, 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 Regulatory Policy Analyst, the incumbent drafts guidance and policy documents; collaborates within CDRH regarding policy development, specifically for medical devices and radiological health products; leads work groups to accomplish these responsibilities and objectives; coordinates with other Centers and Offices within the Food and Drug Administration; analyzes public comments on guidance documents and implementing appropriate revisions; and provides regulatory/policy support regarding the policies and procedures relevant to the development and issuance of CDRH guidance documents.
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 guidance;
- 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.
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 devices; and
- 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.
- Ability to work effectively within teams.
How to Apply
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 February 3, 2021.