Senior Regulatory Affairs Scientist — FDA Strategy & Compliance

CICONIX, LLC; Frederick (MD); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Full benefit program, including health, PTO, & 401k + contribution

Job summary

CICONIX, LLC, located in Fort Detrick, MD, is seeking a Senior Regulatory Affairs Scientist to support the Defense Health Agency and ensure compliance with FDA regulations. The ideal candidate will possess a RAC certification and have experience with regulatory strategy for medical products. This full-time position requires a thorough understanding of regulatory matters related to submissions and communication with the FDA. A comprehensive benefits package is included.

Qualifications

• Possess a Regulatory Affairs Certification (RAC).
• U.S. Citizenship and a successful background investigation are required.

Responsibilities

• Ensure compliance with FDA Sponsor responsibilities.
• Provide regulatory support to an integrated product team.
• Serve as the primary contact with the FDA for assigned products.

Skills

Regulatory Affairs Certification (RAC)

Job description

CICONIX, LLC, located in Fort Detrick, MD, is seeking a Senior Regulatory Affairs Scientist to support the Defense Health Agency and ensure compliance with FDA regulations. The ideal candidate will possess a RAC certification and have experience with regulatory strategy for medical products. This full-time position requires a thorough understanding of regulatory matters related to submissions and communication with the FDA. A comprehensive benefits package is included.