Risk Management Lead

Risk Management Lead#26-01008 Chicago, IL

Fully Remote Job Description At-a-Glance:

Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a Risk Management Lead.

Position Type:

Contract Remote

Required:

8+ years of experience in medical device risk management within a regulated environment. Demonstrated experience leading risk management remediation programs, particularly in response to regulatory findings or compliance gaps. Deep expertise in

ISO 14971

risk management, including application across design controls and post-market risk activities. Proven experience integrating risk management into QMS governance and executive decision-making processes. Strong understanding of FDA regulatory expectations and global standards related to medical device risk management. Experience supporting regulatory inspections, audits, and remediation programs related to risk management findings. Strong leadership, communication, and stakeholder management skills, with the ability to translate complex risk information into actionable insights for senior leadership.

Responsibilities:

Lead system-level risk management remediation initiatives to address gaps in risk integration, escalation, and decision-making across the organization. Conduct assessments of the risk management framework to identify structural gaps and develop remediation strategies aligned with regulatory expectations. Serve as the subject matter expert (SME) for ISO 14971, ensuring consistent interpretation and application of risk management principles across design and post-market activities. Strengthen integration of risk management outputs into QMS processes such as Management Review, CAPA, change control, and governance decision-making. Establish and implement risk escalation pathways, thresholds, and governance mechanisms to ensure critical risk information reaches appropriate leadership levels. Evaluate and remediate post-market risk management processes, ensuring complaints, trends, and nonconformances appropriately inform risk files and benefit-risk assessments. Develop and oversee risk remediation plans, cross-functional execution, and regulatory readiness, ensuring outputs are robust, defensible, and inspection-ready. Get in

Touch:

We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Trusha at 862-895-5719 to learn more. #LI-VK1