AABB is an international, not-for-profit association that represents individuals and institutions involved in the field of transfusion medicine, patient blood management, and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety.
The Deputy Director, Regulatory Affairs prepares, advocates, interprets, and communicates regulatory policy for the Association and its members. The incumbent works as directed with all public health and other relevant agencies, as well as AABB staff to ensure communication of member and association concerns.
- Support the Director - Regulatory Affairs in providing regulatory analysis and proposing policy for key regulatory issues affecting transfusion medicine and related cellular therapies for the Board of Directors and senior management. Prepare AABB positions on proposed rules, guidance documents and items for regulatory advisory committee discussions. Maintain surveillance of regulatory publications and actions and advise on proactive courses of action.
- Support the Director-Regulatory Affairs as a focal point for communications with regulatory and public health agencies, especially FDA and CDC. Advocate positions as needed.
- Represent AABB at public meetings of FDA and other regulatory agencies as designated. Monitor meeting dates and agendas, and determine need for AABB to make public statements. Prepare and deliver statements as needed. Participate in development of public workshops as requested.
- Support and participate in Committees and Interorganizational task forces as designated. Facilitate the development of positions and issue statements, Association Bulletins, and Donor History Questionnaire material and other work product materials as needed. Participate in review processes of these work products from committees and task forces, both internal AABB review, and external with regulatory agencies.
- Provide assistance to members and staff with Regulatory questions. Interpret regulations and guidance and assist members in determining how to meet requirements. When necessary, contact the regulatory agency directly to obtain answers. Determine the need for communication with members on regulatory issues.
- Develop contacts and maintain open lines of communication on regulatory matters with other blood banking and related organizations
- Work directly with other Regulatory and Government Affairs staff. Assist with development of public policy positions consistent with regulatory positions.
- Provide regulatory support and advice to Standards Program Units, Accreditation department, and Consulting Services, including real time response to assessors.
- Provide regulatory support and technical support to the Communications and Public Relations Advise on content for association communications as needed.
- Assist with developing regulatory content for the AABB web site
- Assist with relevant educational sessions at Annual Meeting
- Provide education and training to staff relating to key regulatory issues, as requested.