Regulatory Risk & Quality Manager

CICONIX; Frederick (MD); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health benefits

PTO

401k + contribution

Job summary

CICONIX is seeking a full-time Regulatory Risk & Quality Manager at Fort Detrick, MD. This role supports the Office of Regulated Activities (ORA) and focuses on ensuring compliance with national and international regulations for medical products. Responsibilities include managing knowledge systems, leading audits, and maintaining training compliance. Candidates must be U.S. citizens and able to obtain a security clearance. A comprehensive benefits program is offered, including health, PTO, and a 401k contribution.

Qualifications

• Education: TBD.
• Licensure & Certifications (Current & Unrestricted): TBD.
• Experience: TBD.

Responsibilities

• Provide Knowledge Management and Regulatory Risk and Quality Management support for medical product development.
• Develop and implement knowledge management strategies to improve information flow and collaboration.
• Ensure regulatory compliance for all medical products (drugs, biologics, devices).
• Lead audits and inspections for internal and external customers.
• Document and facilitate risk management activities per ORA SOPs and ISO 14971.

Job description

Regulatory Risk & Quality Manager

Full‑time position

Regular weekly hours (0900‑1600). No calls, nights, weekends, or holidays.

Full benefit program: health, PTO, 401k + contribution.

Location

Fort Detrick, MD.

Job Summary

Support the Office of Regulated Activities (ORA) within the Defense Health Agency Research and Development Medical Research and Development Command (DHA R&D MRDC) at Fort Detrick, MD. The role focuses on regulatory risk and quality management for medical product development, ensuring compliance with national and international regulations and maintaining an audit‑ready training program.

Responsibilities

• Provide Knowledge Management and Regulatory Risk and Quality Management support for medical product development within the ORA.
• Develop and implement knowledge management strategies to improve information flow and collaboration.
• Identify and map critical knowledge to preserve and ensure accessibility.
• Facilitate communities of practice to encourage knowledge sharing and peer‑to‑peer learning.
• Implement and manage knowledge management systems and tools, such as knowledge bases and enterprise search platforms.
• Promote a culture of knowledge sharing and continuous learning.
• Ensure data accuracy and reliability within knowledge systems.
• Analyze knowledge usage to identify improvement opportunities and demonstrate value of initiatives.
• Ensure regulatory compliance for all medical products (drugs, biologics, devices).
• Ensure Quality Management Systems are developed, implemented, and managed in accordance with FDA 21 CFR 820, ISO 13485:2016, and Good Manufacturing Practices.
• Prepare documentation and submission materials, including SOP development and management within ORA.
• Lead audits and inspections for internal and external customers, and regulatory audits such as FDA audits.
• Develop and review CAPAs. Investigate non‑conformances, customer complaints, and other quality issues, determine root cause, and implement CAPAs.
• Document and facilitate risk management activities per ORA SOPs and ISO 14971, including risk analysis, evaluation, and control for new and existing medical products.
• Manage process risk, identifying and mitigating risks associated with manufacturing processes and quality systems.
• Maintain a comprehensive training matrix for all research staff, tracking required courses, renewal dates, and role‑specific needs.
• Continuously monitor and track training compliance of all personnel involved in clinical research.
• Maintain accurate, complete, and up‑to‑date training records for internal audits, sponsor monitoring visits, and regulatory inspections.
• Generate and distribute regular compliance reports, notify relevant parties of training lapses, and oversee remediation.
• Coordinate onboarding and orientation training for new staff.
• Periodically assess training program effectiveness and recommend improvements.
• Perform independent reviews and provide reports on documentation, sites, and facilities to ensure compliance with quality requirements for medical product development and clinical studies.
• Provide subject‑matter expertise and support for developing and implementing in‑house quality systems and procedures, including SOP development for entities conducting non‑clinical, clinical, or manufacturing test articles.
• Provide quality control of deliverables per ORA SOPs, reviewing work products associated with deliverables.
• Offer protocol, project, and procedure‑specific training to ORA, GDIT staff, and personnel at clinical sites, CROs, CMOs, and other supported entities.
• Plan and conduct audits for compliance with applicable regulations for FDA‑regulated medical product development and research.
• Prepare clinical quality assurance management plans IAW Federal Code and guidance documents including 21 CFR Part 312, 21 CFR Part 812, ICH GCP E6, ISO 14155, and applicable government or contractor SOPs.

Qualifications

• Education: TBD.
• Licensure & Certifications (Current & Unrestricted): TBD.
• Experience: TBD.

Security & Background Check

• U.S. citizenship and a successful background investigation are required.
• Ability to obtain and maintain a government security clearance.

Additional Requirements

• Willingness to comply with the government vaccination requirements.

Compensation & Benefits

Position contingent and will begin upon contract award.

Benefits include a full benefit program: health, PTO, 401k plus contribution.

CICONIX LLC is an Equal Opportunity Employer, including disability/vets. We E‑Verify all employees.