Regulatory Affairs Specialist

18 Sep, 2020

Jobs

Regulatory Affairs Specialist

American Society for Microbiology
Washington, DC

Job Details
Description
Essential Functions

Proactively identifies opportunities for ASM federal policy engagement with regulatory agencies, specifically, the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA).
Monitors, analyzes and reports on regulatory activity that has the potential to affect the microbial sciences community in assigned policy areas, including diagnostic regulation, coding and reimbursement.
Provides timely updates on policy issues for staff and volunteers.
Works with ASM members to develop position statements, testimony, and regulatory comments.
Ensures a strong presence with specific regulatory agencies
Represents ASM in coalitions with whom the Society is engaged and identifies new partnership opportunities
Collaborates effectively with diverse stakeholders and partners working to address issues that impact the microbial sciences, especially the clinical microbiology area
Work directly with volunteer committees and volunteer leaders

Qualifications
Behaviors
Preferred

Enthusiastic: Shows intense and eager enjoyment and interest

Functional Expert: Considered a thought leader on a subject

Team Player: Works well as a member of a group

Innovative: Consistently introduces new ideas and demonstrates original thinking

Detail Oriented: Capable of carrying out a given task with all details necessary to get the task done well

Dedicated: Devoted to a task or purpose with loyalty or integrity

Motivations
Preferred

Self-Starter: Inspired to perform without outside help

Goal Completion: Inspired to perform well by the completion of tasks

Flexibility: Inspired to perform well when granted the ability to set your own schedule and goals

Ability to Make an Impact: Inspired to perform well by the ability to contribute to the success of a project or the organization

Education
Required

Bachelors or better in Microbiology.

Experience
Required

Federal policy engagement with regulatory agencies, specifically, the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA
Knowledge of clinical laboratory practices, research and the relationship to policy issues, including federal agency regulations of health care required
5 years: Capitol Hill, in a federal agency, or with a professional, scientific, or clinical health care association with a focus on policy
Preferred

Learn more here

Job posted: 2020-09-18