Regulatory Affairs Scientist
Reasonable Accommodation Statement:
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
- Serves as a core member of integrated product teams (IPTs) and member of internal regulatory teams in support of drug, biologic, and medical device products, which includes:
- Reviewing of all regulatory documentation for the product development effort to include reviewing, editing, and coordination of document submissions to the FDA;
- Identifying regulatory issues that need input of other regulatory Subject Matter Experts (SMEs) and obtaining that input; aiding with clinical and nonclinical protocol development and review; providing guidance on regulatory pathway development and regulatory strategy;
- Providing guidance to IPTs in the conduct of meetings with the FDA;
- Providing guidance to IPTs for development of contract documents and statement of works for the development of medical devices, drugs or biologic products
- Ensure all FDA communications, both formal and informal are documented in the Sponsors Electronic Document Management System (EDMS) for Army Surgeon General sponsored products;
- Ensuring timely receipt of and providing regulatory review of all FDA communications for externally sponsored products, serve as a point-of-contact with FDA and regulatory staff of external collaborators.
- Providing regulatory assessment, consult, and regulatory opinion for medical devices, drugs, biologics
- Understand and apply Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP) or Quality Systems Regulation (QSR) compliance for medical devices.
- Establishing and complying with standard operating procedures.
- Populating the sponsor’s trial master file for clinical studies and perform audits of trial master files to ensure all documentation is included
- Assists in the tracking/reporting of the Army Surgeon General sponsored drug, biologic, and medical device products; as well as any required Annual Report due dates and maintenance of relevant file shares and the SERF. The Contractor shall assist in the completion of FDA forms (e.g. 1571, 1572, 2252) per 21 Code of Federal Regulations (CFR) and/or USAMMDA policy and/or regulations.
- Supports the Common Technical Document requirements (CTD) and electronic CTD (eCTD) publishing for drug/biologic product development efforts. The Contractor shall support the appropriate FDA premarket and post market regulatory requirements for medical device development efforts.
- Assists in the preparation of document output that meets requirements for publishing documents that interact appropriately with sponsor and/or regulatory agency software systems/programs. The Contractor shall ensure that all final electronic deliverables meet current regulatory electronic document requirements and guidance.
- Masters or better in Biodmedical Science or related field
- Experience in advising product development teams on regulatory issues.
- Solid understanding of the FDA eCTD processes.
- Experience in coordination of regulatory activities within internal and external teams.
- Experience in GLP studies and GCP Regulations.
- Experience applying FDA Title 21 CFR for clinical research, regulatory compliance and quality review of submissions to the FDA relating to product approval; regulatory affairs guidance and policy document development, regulations and guidelines to ensure FDA clinical research compliance, and regulations and guidelines to ensure compliance to design controls for the development of devices is required.
- Prior experience as an FDA regulatory scientist or experience representing a sponsor before the FDA
- Experience in medical product development.
- Understand the risk-based device classification system for medical devices and regulatory requirements of the three classes of medical devices (Class I, II, III devices).
- Ablility to work independently following a brief period of specific technical training
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Job posted: 2020-03-16