Director, Regulatory Affairs
America’s Blood Centers
America’s Blood Centers (ABC), North America’s largest network of community-based, independent blood programs, is seeking a Director, Regulatory Affairs. The position will be actively involved and accountable for the development, implementation, execution and advancement of the ABC regulatory agenda before federal agencies and other stakeholders. In addition, the position will assist in the facilitation of member education, evaluation and coalescing of member input in the development of industry positions, data collection from internal and external sources, and primary and secondary research.
The position will report directly to the Senior Director, Federal Government Affairs, providing strategic guidance on regulatory affairs and public policy issues pertaining to the nation’s blood supply.
- Analyze, evaluate, communicate, and track regulatory developments and their impact on ABC member centers, including working with members and staff in the development of policy positions, public statements, comment letters and responses to information requests from federal agencies.
- Assist in the development and execution of the ABC Advocacy Agenda, including environmental scanning for new and emerging public policy issues. Assist in developing strategies to advance advocacy objective through regulatory agencies, including member education on the regulatory environment.
- Build strategic relationships as a liaison with appropriate staff at the Food and Drug Administration (FDA) and other federal agencies as necessary (including HHS, OSHA, DOL, NCR, CDC, DOD, and others), and non-governmental industry partners.
- Analyze emerging issues in the areas of science, medical, and technical (SMT) affairs to assess their potential impact on regulations and other public policy initiatives.
- Serve as an ABC representative and spokesperson to industry coalitions, including, but not limited, to the FDA Liaison Committee and AABB Interorganizational Disaster Task Force.
- Provide regular updates to ABC members and staff of SMT and regulatory issues with impact on their operations, including Member Communication Notices (MCNs), development of webinars, and presentations.
- Research and respond to individual member requests for information and assistance in regulatory areas (clarification of guidelines, assistance in interactions with FDA, etc.).
- Assist in the development of programs and resources that support member activities in regulatory areas and implementation of new guidance and regulations.
- Conduct routine operational and ad hoc member surveys that support the ABC Advocacy Agenda and ABC member operational excellence. Work includes the creation of survey forms and protocols, analysis of data, and preparation and dissemination of reports.
- Write articles for the ABC Newsletter and other member publications as requested.
- Provide support and counsel to ABC members, senior staff, and the CEO; advise senior officers on all related matters of interest and concern to the Association.
- Work on special projects and other duties as required helping to promote the association’s success.
- Travel Requirements: local, plus domestic travel accounting for 5% of the year.
Experience, Knowledge, Skills and Abilities:
- Thorough understanding of the federal regulatory processes and landscape, particularly with the Food and Drug Administration.
- Knowledge of and experience in health policy.
- Blood industry knowledge preferred, but not required.
· Ability to collect, analyze, and synthesize information from varied sources.
- Strong critical thinking, analytical, and problem-solving skills.
- Self-motivated and goal oriented.
- Ability to multitask and determine priorities.
- Ability to network and collaborate effectively with colleagues and volunteers.
- Strong communication skills – verbal, written, and presentation.
- Ability to travel, sometimes at short notice.
This position is based in Washington D.C.
America’s Blood Centers employs talented individuals whose passion, drive and skills are necessary to fulfill our mission. America’s Blood Centers offers a salary commensurate with experience as well as an excellent benefit package including medical, dental, LTD, and 401k contribution. We are a hybrid virtual office that promotes a flexible work environment. Applicants must be able to maintain a safe, separate workspace in which they can complete their work that is free from distraction and limits accessibly by non-employees and live in an area where they can obtain reliable internet service. This is a full-time staff position including benefits and a stipend for internet and telephone services.
America’s Blood Centers prohibits discrimination and provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Interested applicants should send a cover letter and resume to firstname.lastname@example.org.
Job posted: 2020-02-04