Program Director, Regulatory Affairs
American Red Cross, Biomedical Services Division
The American Red Cross Biomedical Services Quality and Regulatory Affairs Department contributes to the mission of the Red Cross by working with functional areas to establish quality, compliance and regulatory strategies. We are currently seeking a Program Director of Regulatory Affairs. Reporting directly to the Executive Director of Regulatory Affairs and Compliance.
The Program Director, Regulatory Affairs,
- Contributes to the development, implementation, and execution of strategies to ensure compliance with Red Cross regulatory obligations, including governmental regulatory standards and agency guidelines.
- Advises the Executive Director on key regulatory issues facing the organization and the Regulatory Affairs department.
- Partners with all Biomedical Services functional groups to establish regulatory strategies and coordinate submissions across the business unit.
- Serve as a liaison between the American Red Cross and various governmental agencies and regulatory bodies, including the FDA, on regulatory issues.
- May serve as the designee for the Executive Director, as appropriate.
- Support regulatory affairs functions, including regulatory submissions such as product licensure requests, and ensure tracking of all regulatory communications, especially those related to compliance.
- Coordinating and preparing document packages for regulatory submissions from all areas of Biomedical Services, including facility registration, license supplements, amendments, and/or inquiries.
- Lead strategic analysis and development of responses to FDA Form 483s and other regulatory inspection or audit reports.
- Serves as regulatory liaison on project teams throughout the product lifecycle
- Define regulatory requirements and develop regulatory approach to support implementation and optimization of efforts to grow segment-specific sales and the overall impact to the Biomedical business.
- Provides strategic direction to project teams on the development of submissions and inquiries with regulatory agencies.
- Responsible for review of new or revised regulations or guidance documents and development and submission of Red Cross comments to relevant regulatory body
- Facilitate analysis and impact of proposed federal and state regulations and advise senior/executive management on these issues.
- Represent the American Red Cross in dealing with the Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services (CMS) state agencies and trade associations.
- Monitor and ensure labeling promotional materials are compliant with FDA regulations.
- Education: 4-year college degree or equivalent combination of education and experience Political Science, Public Policy or related field.
- Experience: Minimum 10 to 15 years required.
- Essential Functions/Physical Requirements: Depending on work assignment, may require ordinary ambulatory skills sufficient to visit other locations; or the ability to stand, walk and manipulate (lift, carry, move) light to medium weights of up to 20 pounds. Requires good hand-eye coordination, arm, hand and finger dexterity, including ability to grasp, and visual acuity to use a keyboard, operate equipment and read technical information. Overall mobility is essential.
- May include sitting for long periods of time, driving a vehicle and working under challenging conditions.
- Work Conditions: Work is performed indoors with some potential for exposure to safety and health hazards related to emergency services relief work. May travel and participate in meetings and conferences throughout chapter jurisdiction, state and Red Cross system. Because the Red Cross is a disaster response organization, staff may be asked to be on 24-hour call during period of major disaster.
Apply now! Joining our team will provide you with the opportunity to make a difference every day.
The American Red Cross is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
The American Red Cross is a diverse nonprofit organization offering its employee’s professional development and growth opportunities, a competitive salary, comprehensive benefits, and a collaborative team spirit environment. To be considered for this position, please visit www.redcross.org/jobs to apply.
Job posted: 2020-10-07