ECI ยท 8 hours ago
Risk Management SME #9350
San Diego, CA
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expECI is a global leader in professional consulting services for the life sciences industry, committed to providing transformative solutions. They are seeking an experienced Risk Management Subject Matter Expert (SME) to support quality system remediation efforts and improve risk management programs in alignment with regulations and standards.
BiotechnologyConsultingLife ScienceProject Management
No H1B
Responsibilities
Serve as a subject matter expert in Risk Management processes and best practices
Conduct gap analysis of the existing Quality Management System (QMS) and Risk Management programs, including: Policies, procedures, work instructions, forms, and collateral documentation
Evaluate and assess existing QMS Procedures, work instructions, electronic process, and risk management files (RMFs), including records and documentation against 21 CFR 820 and ISO 13485
Prepare and submit comprehensive Assessment Reports detailing findings and areas for remediation
Develop a Quality Plan outlining corrective actions and improvement strategies to address identified gaps
Implement, instruct, and train staff on Risk Management remediation directives in compliance with regulatory requirements
Ensure all remediation efforts meet applicable regulatory and quality standards
Interface and collaborate with other subsystems or teams to ensure alignment and integration of risk remediation activities
Participate in meetings, reviews, and discussions to support ongoing compliance and continuous improvement
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, Quality Assurance, or a related field
Minimum of 10+ years of experience in Medical Device Risk Management
Strong knowledge of international standards such as ISO 14971, ISO 13485, FDA 21 CFR Part 820
Proven experience conducting gap assessments and remediation planning
Strong technical writing, communication, and project management skills
Ability to work independently and as part of a cross-functional team
Company
ECI
ECI (Enhanced Compliance Inc.) stands as a beacon of excellence in the life sciences consulting arena.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Michael Boyer
Chief Financial Officer
Shital Patel
Chief Operating Officer
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