As a member of the Quality and Regulatory team, the Regulatory Affairs Coordinator is responsible for coordinating regulatory related activities for CBR, including regulatory inquiries, internal and external audits, and providing regulatory inputs on company processes and initiatives.
Responsibilities:
Assist in developing procedures to ensure regulatory compliance to governing standards from the FDA, ISO, AABB, and other regulatory bodies.
Be familiar with a variety of regulatory concepts, practices, and procedures.
Use experience and judgment to plan and accomplish goals.
Coordinate and participate in external and internal audits, as required.
Coordinate the Management Review process.
Respond to or coordinate any external audit non-conformities.
Keep current with Federal, State, and National standards as they apply to cord blood and cord tissue banking.
Provide department and employee training on regulatory matters.
Monitor and communicate changes in regulatory requirements to company management.
Prepare, review, and submit requested documentation to FDA, AABB, and other regulatory agencies.
Notify applicable agencies of reportable events.
Work closely with the Quality and Regulatory Affairs Director to develop strategies for continuous improvement of the Quality System.
Review and report on reportable events, adverse reactions, and complaints.
Participate in document review and approval.
Requirements:
Bachelor’s degree (B. S.) from four-year college or university and four years related experience and/or training; or equivalent combination of education and experience.
Able to adapt quickly to an ever changing environment.
Passionate about contributing to a quality system.
Criminal background screening, post-offer drug testing, and reference checks are a condition of employment
Interested candidates should send a resume to CBRCareers@cordblood.com