Regulatory Relations Specialist files applications and interacts with governmental officials during the regulation and certification process for a plant or other facility. Assists in developing procedures to ensure regulatory compliance. Being a Regulatory Relations Specialist gathers data pertaining to organizational projects and their impact on the regulation process. May require a bachelor's degree. Additionally, Regulatory Relations Specialist typically reports to a supervisor or manager. To be a Regulatory Relations Specialist typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. (Copyright 2024 Salary.com)
Founded in 1954, Blood Bank of Delmarva (BBD) is a non-profit, community-based blood center providing blood and blood products to hospitals in the Delmarva region. The Quality and Regulatory Affairs department is responsible for protecting the safety of the donors and patients we serve by ensuring that organizational policies, processes, and practices comply with quality system essentials and regulatory requirements of federal, state, local and industry focused agencies. The department also works with BBD leadership to promote a culture of quality and continuous process improvement. This position is a rewarding opportunity to have a hands-on role in ensuring a safe, effective blood supply for the patients in our community. BBD is FDA licensed, a member of America's Blood Centers, and accredited by AABB.
The Regulatory and Audit Compliance Specialist (“Specialist”) is responsible for developing and maintaining a risk-based quality auditing program for the New York Blood Center Enterprise division. The Specialist monitors and evaluates divisional compliance with regulatory requirements, professional accreditation standards and internal policies and procedures to ensure the ongoing quality and safety of products and services.
Additionally, the Specialist is responsible for regulatory and accreditation activities related to cGxP manufacturing and clinical and laboratory services at the NYBCe division. These include, but are not limited to, activities regulated by the FDA (Food and Drug Administration), AABB (Association for the Advancement of Blood and Biotherapies), (FACT) Foundation for the Accreditation of Cellular Therapy, state departments of health, state laboratories, blood and tissue regulators, and CMS (Center for Medicare and Medicaid Services) / CLIA (Clinical Laboratory Improvement Act).
Education:
Bachelor's degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management. Bachelor’s degree in another field of study may be considered with strong, relevant work experience.
Related Experience
Minimum three years’ experience performing quality audits in a related, highly regulated environment, preferably in the blood, biologics or pharmaceutical industries.
Experience implementing, interpreting, and providing guidance on U.S. regulations for biologics, or providing quality assurance oversight in blood or biologics industry is preferred.
Any combination of education and experience equivalent to the requirements listed above has supplied the necessary knowledge, skills, and experience to perform the essential functions of the job equivalent to the job requirements above.
Preferred Qualifications:
American Society for Quality (ASQ) Certified Quality Auditor (CQA) or ISO Lead Auditor certification.
Experience as an ISO-9000, FACT, CAP or AABB Assessor is a plus.
Understanding of the manufacture and testing of blood, cellular and gene therapies is desirable.
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0 Regulatory Relations Specialist jobs found in Delaware City, DE area