Regulatory Risk & Quality Manager
No salary listed
Mid
Frederick, MD, USA
In Person
Biology & BiotechRegulatory & Quality (Life Sciences)
No H1B Sponsorship
US Citizenship Required
About the job
Requirements
- U.S. citizenship is required.
- A successful background investigation is required.
- Ability to obtain and maintain a government security clearance is required.
- Willingness to comply with government vaccination requirements is required.
Responsibilities
- Provide knowledge management and regulatory risk and quality management support for medical product development within the Office of Regulated Activities.
- Apply expertise in relevant laws, regulations, and industry best practices to help mitigate regulatory risk and maintain product quality and safety.
- Ensure compliance with applicable national and international regulations and standards.
- Ensure personnel conducting clinical human research receive appropriate training in accordance with institutional policies, sponsor requirements, and applicable federal regulations, including Good Clinical Practice.
- Develop and implement knowledge management strategies to improve organizational information flow and collaboration.
- Identify and map critical organizational knowledge to ensure its preservation and accessibility.
- Facilitate communities of practice to encourage knowledge sharing and peer-to-peer learning.
- Implement and manage knowledge management systems and tools, including knowledge bases and enterprise search platforms.
- Promote knowledge sharing and continuous learning among employees.
- Ensure data accuracy and reliability within knowledge systems.
- Analyze knowledge usage and effectiveness to identify improvements and demonstrate the value of knowledge management initiatives.
- Ensure regulatory compliance for medical products, including drugs, biologics, and devices, under applicable guidance and regulations.
- Develop, implement, and manage Quality Management Systems in accordance with relevant standards, including FDA 21 CFR 820, ISO 13485:2016, and Good Manufacturing Practices.
- Prepare documentation and submissions and manage submissions, maintenance, and standard operating procedures within the Office of Regulated Activities.
- Lead internal and external audits and inspections, including regulatory audits such as FDA audits.
- Develop and review corrective and preventive actions; investigate non-conformances, customer complaints, and other quality issues to determine root causes and implement corrective and preventive actions.
- Facilitate and document risk management activities in accordance with Office of Regulated Activities standard operating procedures and ISO 14971, including risk analysis, evaluation, and control for new and existing medical products.
- Identify and mitigate process risks associated with manufacturing processes and quality systems.
- Maintain a comprehensive training matrix for research staff, including required courses, renewal dates, and role-specific educational needs.
- Monitor and track training compliance for personnel engaged in clinical research, including principal investigators, sub-investigators, and clinical research coordinators.
- Maintain accurate, complete, and current training records for research personnel and ensure they are available for internal audits, sponsor monitoring visits, and regulatory inspections.
- Generate and distribute regular compliance reports, promptly notify relevant parties of training lapses, and oversee remediation.
- Coordinate and document initial training for new staff members.
- Assess training-program effectiveness and recommend improvements or additional training modules to address emerging compliance trends or corrective actions.
- Conduct independent reviews and report on documentation, sites, organizations, 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 writing standard operating procedures to support Office of Regulated Activities compliance.
- Survey personnel, review procedures, assess facilities, and write standard operating procedures for entities conducting or assisting with non-clinical studies, clinical studies, or manufacturing test articles.
- Provide quality control of contract deliverables by reviewing associated work products when requested and in accordance with Office of Regulated Activities standard operating procedures.
- Provide protocol-, project-, and procedure-specific training to Office of Regulated Activities and GDIT staff, clinical sites, contract research organizations, contract manufacturing organizations, and other supported entities.
- Plan and conduct audits of compliance with applicable regulations governing the development and research of FDA-regulated medical products, including preparing written audit plans and reports.
- Prepare clinical quality assurance management plans in accordance with federal code, guidance documents, including 21 CFR Parts 312 and 812, ICH Good Clinical Practice E6, and ISO 14155, and approved government or contractor standard operating procedures.
About the company
CICONIX provides an integrated suite of consulting and diagnostic support services for health and human services challenges, with a particular focus on program development and biomedical research assistance to advance healthcare for America's Warfighter community. Its offerings combine advisory services and diagnostic support to help clients design and implement programs, guide biomedical research efforts, and identify opportunities to improve operations across their business lines. The company differentiates itself through its end-to-end, integrated approach and its specialization in military healthcare needs, along with a commitment to maintaining a strong work-life balance for its employees. CICONIX aims to help clients capitalize on opportunities for enhanced operational success while delivering a supportive workplace for its staff.
Company Size
11-50
Company Stage
N/A
Total Funding
N/A
Headquarters
Annapolis, Maryland
Founded
2012
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Simplify's Take
What believers are saying
- CICONIX won a $4.08 million NICoE task in July 2026.
- FY2026 already shows nine award actions and $333,292 net obligations.
- Federal award history totals $55.2 million across 25 awards, proving repeat demand.
What critics are saying
- CICONIX depends heavily on DoD and DHA; losing recompetes hits revenue fast.
- The 2026 STARS III option ends July 1, 2026, forcing renewal pressure.
- Employee reviews in 2026 cite hostile management, weak job security, and cut-and-run behavior.
What makes CICONIX unique
- CICONIX specializes in warfighter healthcare, clinical research, and federal health support contracts.
- It holds OASIS+, SeaPort NxG, and GSA STARS III vehicles.
- Its integrated consulting and diagnostics model fits defense health clients' administrative needs.
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Benefits
- Health Insurance
- Paid Vacation
- Relocation Assistance