The Director, Regulatory and Governmental Affairs establishes and communicates the AATB official position regarding critical regulatory issues, that may impact AATB member organizations, to the Food and Drug Administration (FDA) and other applicable governmental and standard-setting organizations. Provides their expert interpretation, guidance, strategy and counsel on existing laws, regulations, standards, and guidance that impact AATB members. Works in a collaborative team environment to assure cross-functional alignment of the mission, goals and activities that bring value to the membership.
Working in concert with the CEO, Vice President Accreditation and Standards, the TPG leadership and Hart Health Strategies, is responsible for the development and establishment of strategies, policies, and plans, which align with government laws, regulations and standards.
Leads analysis of proposed Federal and State legislative actions to determine the potential impact on AATB member organizations and develops appropriate response(s).
Prepares official response(s) to governmental and standard-setting authorities regarding new and/or changes to Federal and State laws, regulations, and guidance.
Functions as AATB’s official liaison with FDA and other applicable regulatory authorities.
Functions as the AATB spokesperson on potential and existing applicable FDA and other relevant government regulations and guidance as well as other relevant standard-setting organizations.
Participates in AATB meetings including but not limited to AATB Board of Governors, TPG, AATB Councils and Committee meetings as requested.
Organizes and participates in meetings or conference calls between AATB and representative (s) from FDA or other governmental regulatory or standard-setting authorities regarding regulatory issues that may impact AATB members.
Coordinates Hart Health Strategies activities or other future lobbying groups or regulatory consultants including negotiations of terms and conditions. Reviews and evaluates work product and activities on behalf of AATB
Provides support to member organizations involving local, state, and federal government affairs.
Interface regularly with the Standards Committee assuring that the AATB Standards are aligned with regulatory requirements and anticipate future changes.
Provide regular written updates for the AATB membership on regulatory and governmental affairs activities, including those of Hart Health Strategies or other future lobbying groups or regulatory consultants and the AATB Tissue Policy Group.
Administer AATB research grant program in collaboration with Standards and Technical Affairs Committee.
Required Education and Experience
Bachelor’s degree with Master’s degree preferred. Equivalent experience may be considered at the discretion of the association.
10 years experience in regulatory affairs and/or compliance experience working in the tissue, medical device, drug and/or biologics field or other FDA regulated industry.
CTBS and RAPS certified highly desired.
Required Competencies and Interpersonal Skills
Must possess in-depth knowledge, understanding and experience with interpretation of FDA regulations, ISO standards, and other governmental regulations and standards associated with tissue banking, medical devices, drugs and/or biologic products.
Ability to work with minimal supervision, take initiative and make independent decisions with a high degree of critical thinking.
Highest level of professionalism with the ability to maintain confidentiality.
Expert level skills in professional communications with a multi-faceted customer group and ability to positively problem solve where differing opinions may be varied with internal and external stakeholders.
Demonstrated ability to develop and deliver presentations to a wide range of constituents and audiences.
Proven ability to manage time, prioritize multiple tasks, meet deadlines, and maintain high-quality attention to detail.
Proficient in software applications required to support job duties.
Telecommuting is allowed.
Internal Number: 013
About American Association of Tissue Banks
The American Association of Tissue Banks (AATB) is a professional, non-profit, scientific and educational organization. It is one of the only national tissue banking organizations in the United States, and its membership totals more than 125 accredited tissue banks and 2,000 individual members. These banks recover tissue from more than 30,000 donors and distribute in excess of two million allografts for more than 1.75 million tissue transplants performed annually in the U.S. The overwhelming majority of the human tissue distributed for these transplants comes from AATB-accredited tissue banks.