Regulatory Systems Manager

About the Position: MRDC is now part of the Defense Health Agency (DHA) Research & Development (R&D). We are the medical materiel developer, with responsibility for medical research, development and acquisition. Our expertise in these critical areas helps establish and maintain the capabilities the military needs to remain ready and lethal on the battlefield. Please visit our website https://mrdc.health.mil/ This is a Direct Hire Solicitation

Major duties

• Ensure the Food and Drug Administration (FDA) regulated IT systems, programs, and processes comply with Federal, Defense Health Agency (DHA) and Medical Research and Development Command (MRDC) regulations and policies.
• Manage user accounts, training, and issues for Office of Regulated Activities (ORA) regulatory systems.
• Write, edit, and manage standard operating procedures (SOPs) and policies to ensure that ORA’s regulated and quality systems stay up to date and compliant with current regulations.
• Asses current and potential FDA regulated systems, processes, and policies for compliance and effectiveness using documented, metric-based, approaches.
• Oversee creation, editing, and submission of electronic common technical document (eCTD) compliant documents and manage our eCTD templates.
• Perform and oversee regulatory compliance and quality reviews of submissions to the FDA.
• Build and oversee a comprehensive quality management system at ORA.
• Work with ORA staff to identify and mitigate quality and regulated IT systems risks.

Qualifications

Who May Apply: US Citizens DHA Research & Development (R&D) is participating in an alternative personnel system known as the Personnel Demonstration Project (PDP). The DB-03 payband is equivalent to the GS-13 step 1 to GS-14 step 10 level. In keeping with the Demonstration pay fixing policies, employees earning a salary that falls within this payband equivalent, may not receive an immediate pay increase (promotion) if appointed to this position. Future pay increases within the payband will be accomplished through the pay for performance management system. This is a Direct Hire Authority (DHA) solicitation utilizing the DHA for Certain Personnel of the DoD Workforce to recruit and appoint qualified candidates to positions in the competitive service. In order to qualify, you must meet the education and experience requirements described below. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community; student; social). You will receive credit for all qualifying experience, including volunteer experience. Your resume must clearly describe your relevant experience; if qualifying based on education, your transcripts will be required as part of your application. Additional information about transcripts is in this document. Basic Requirement for Regulatory Systems Manager: Degree: Bachelor's or graduate (or higher level) degree with major study in an academic field related to the medical field, health sciences, or allied sciences appropriate to the work of the position. This degree must be from an educational program accredited by an accrediting body recognized by the U.S.Department of Education at the time the degree was obtained. You MUST submit copies of your transcripts supporting your education. In addition to meeting the basic requirement above, to qualify for this position you must also meet the qualification requirements listed below: Specialized Experience: One year of specialized experience which includes:

1. Experience working with or managing FDA compliant regulated IT systems, such as: EDMS, Lorenz,Argus, EDC, etc.
2. Experience drafting, editing, and formatting documents in compliance with electronic common technical document (eCTD) standards.
3. Experience developing and implementing new policies and procedures involving regulated systems,quality management systems, and/or clinical trials, including training, enforcement, and tracking performance metrics.
4. Experience leading a diverse team of technical experts in a regulated systems field. This definition of specialized experience is typical of work performed at the next lower grade/level position in the federal service (DB-02 / GS-12).

Education

Some federal jobs allow you to substitute your education for the required experience in order to qualify. For this job, you must meet the qualification requirement using experience alone--no substitution of education for experience is permitted. FOREIGN EDUCATION: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit: https://sites.ed.gov/international/recognition-of-foreign-qualifications/.