The Regulatory Compliance Associate works with NMDP staff and network partners to support processes and systems within the NMDP to assure compliance with Food and Drug Administration (FDA) and other applicable regulations. Primary compliance accountabilities include preparation and coordination of compliance documentation submissions, IND support and reporting, Adverse Events, and Quality Incident reporting. Partners with department to ensure regulatory compliance documentation and conducts training.
Minimum Education:
Bachelors degree in medical technology or other health science-related field. On evaluation, three to five years in a quality assurance or regulatory compliance role, in addition to the minimum experience described below, may be substituted for the degree requirement.
Minimum Experience:
Three or more years experience in a position which required the application of quality systems within the regulated medical industry. Experience must include at least two years experience working with GMP requirements and with the application of QA principles. Demonstrated experience working with team to successfully integrate regulations.
Experience in research or managing IND or licensure documentation and ASQ certification preferred.
Key Knowledge:
Intermediate applied knowledge of Federal Regulations (CFR) requirements pertinent to pharmaceutical, biologic or medical device required. Knowledge of auditing practices and principles and Auditor Certification preferred (CQA, etc.).
Key Skills:
Interpersonal skills to effectively accomplish outcomes through the work of others. Ability to meet deadlines and manage multiple projects and tasks simultaneously; write and communicate articulately; utilize Word and Excel software systems; strong interpersonal skills; work independently and as part of a team
Other Requirements:
National Marrow Donor Program - 6 months ago
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