Regulatory Health Scientist
Remote
Job Id:
160578
Job Category:
Job Location:
Remote
Security Clearance:
Public Trust or Uncleared
Business Unit:
Piper Companies
Division:
Piper Clinical Solutions
Position Owner:
Nora Walsh-Battle
Piper Companies is seeking a Regulatory Health Scientist to support a healthcare agency through a fully remote role. This position centers on applying advanced regulatory, scientific, and technical expertise to strengthen medical countermeasure (MCM) programs, with a strong emphasis on FDA requirements for drugs, vaccines, biologics, and medical devices used in public health preparedness and emergency response.
Responsibilities of the Regulatory Health Scientist include:
- Act as a key subject matter expert on FDA regulatory pathways—including IND, EUA, IDE, and related processes—offering strategic guidance for medical devices, drugs, and biologics.
- Oversee the creation, review, maintenance, and lifecycle management of regulatory submissions and updates across a diverse portfolio of medical countermeasures.
- Contribute to and refine regulatory strategies for products managed within the Strategic National Stockpile (SNS) and CDC portfolios, ensuring alignment with federal policies and current FDA guidance.
- Perform detailed evaluations of scientific and clinical data to support public health preparedness, emergency response initiatives, and regulatory decision-making.
- Partner with federal subject matter experts and maintain up-to-date knowledge of evolving regulatory policies, scientific advancements, and guidance to enhance MCM readiness and regulatory compliance.
Qualifications for the Regulatory Health Scientist include:
- An advanced degree in public health, regulatory science, pharmacy, medicine, nursing, or a related scientific field.
- A minimum of one (1) year of experience supporting FDA regulatory operations for medical products.
Compensation for the Regulatory Health Scientist includes:
- Pay Range: Flexible based on experience
- Comprehensive Benefits: Medical, Dental, Vision, 401K, Sick Leave as required by law
This job opens for applications on 02/20/2026. Applications for this job will be accepted for at least 30 days from the posting date.