Health Scientist - Quality & Compliance Lead (CDRH)

U.S.-Food-and-Drug-Administratio; Hillandale (MD); On-site; USD 90,000 - 130,000; Full time

Job summary

The U.S. Food and Drug Administration in Maryland seeks a General Health Scientist to join the CDRH team.

The role requires leading independent quality assessments, audits, and compliance evaluations of FDA review activities, applying judgment to identify improvement opportunities and corrective actions. Applicants must have a relevant health sciences degree and meet specific experience requirements by the stated deadline.

Qualifications

• Bachelor's degree or higher in health sciences from an accredited program.
• Applicants must submit transcripts to prove education.
• Experience: 5y (Bachelor), 4y (Master), 2y (Doctorate/JD/MD) leading quality assessments.

Responsibilities

• Lead independent quality assessments, audits, and compliance evaluations of CDRH review activities.
• Apply authoritative judgment to identify improvement opportunities and deficiencies.
• Develop corrective action recommendations and track closures per FDA standards.

Skills

Quality assessments

Audits

Compliance evaluations

Regulatory requirements

Quality management

Education

Bachelor's degree or higher in health sciences

Job description

The U.S. Food and Drug Administration in Maryland seeks a General Health Scientist to join the CDRH team.

The role requires leading independent quality assessments, audits, and compliance evaluations of FDA review activities, applying judgment to identify improvement opportunities and corrective actions. Applicants must have a relevant health sciences degree and meet specific experience requirements by the stated deadline.