Regulatory Affairs Scientist (Devices)

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.

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 Affairs Scientist (Devices): 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 interacting with varied groups and types of internal and external stakeholders to provide regulatory support across Food and Drug Administration (FDA) regulated research and development efforts. 2. Experience providing regulatory affairs guidance for medical research programs which develop medical device products. 3. Experience studying, interpreting, implementing, and/or providing regulatory guidance on relevant local, national, and/or international medical research regulations 4.

Experience complying with Food and Drug Administration (FDA) regulations and guidelines including conducting quality reviews of FDA submissions for product approval 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). Regulatory Affairs Certification in Medical Devices is Desired (Not Required)