Medical Device Risk Management Advisor
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
AI-powered platform feedback advisor for medical device risk management and regulatory documentation. Provide expert insights to shape product features and workflows based on real-world experience.
Responsibilities:
- Test new features and prototypes periodically
- Provide feedback on usability and regulatory alignment
- Review risk management and documentation workflows
- Suggest improvements based on real industry practice
- Join occasional 30–45 minute feedback sessions
Requirements:
- Medical device regulatory affairs or quality assurance
- Experience with ISO 14971 risk management
- Design controls / DHF documentation
- 510(k), De Novo, or PMA experience is a plus
- Risk management file, FMEA, or hazard analysis experience
Benefits:
- Flexible, part-time opportunity
- Consultants and industry professionals are welcome

FocusKPI, Inc.
IT Services and IT ConsultingFocusKPI is a data science and technology firm specializing in predictive analytics practice and methodologies.
Similar Jobs

Group Risk Specialist – Governance and Control
Group Risk Specialist providing risk management expertise to support the 1B team at TD. Collaborating across priorities for risk assessments, governance routines, and regulatory change management.

Data Governance Student Worker
Student Worker in data governance supporting projects and programs at OHSU. Providing general administrative support for the Data Governance Program and Office.

Head of Risk
Head of Risk responsible for establishing and maintaining risk management framework in El Salvador. Collaborating with senior leadership to mitigate risks in fintech environment.

Senior Business Analytics Manager – Trend Analytics, Risk Ecosystem
Senior Manager leading analytics to design clinical and affordability insights for Cigna Healthcare. Collaborating across teams to deliver trend analysis and improve decision-making.

Risk Control Consultant
Risk Control Consultant providing evaluations and consultative services in a remote setting. Working with global teams and developing risk control strategies for complex accounts.

Insider Risk Analyst – SkillBridge Intern
Insider Risk Analyst - SkillBridge Intern at Zscaler focusing on behavioral analysis and data protection. Part of Enterprise Security team defending Zscaler's infrastructure and data.

Data Governance Risk Analyst
Data Governance Risk Analyst improving data management and risk governance at Banner Bank. Collaborate cross-functionally to ensure data is trusted and aligned to enterprise risk standards.

Senior Manager, Controls & Governance
Senior Manager of Controls & Governance leading operational controls and frameworks for fiber construction at Zayo. Manage performance, reporting, and decision-making in complex projects.

Data Quality and Governance Analyst 2
Data Quality and Governance Analyst building a data governance program for a major consumer goods client. Establishing frameworks and standards to transform real estate data for business decisions.

Pricing & Risk Director
Lead Kin’s Pricing & Risk Management department focused on pricing strategy and risk frameworks. Collaborate with executives to align decisions with market realities and regulatory expectations.

Risk Manager I
Risk Manager I managing risk segmentation strategies for TD Bank, providing detailed analyses and implementing risk management policies. Collaborating with cross-functional teams to enhance credit assessment capabilities.

Risk Analyst
Risk Analyst role at Patriot Software, focused on fraud protection through thorough application and identity checks. Collaborating with teams to ensure compliance and develop secure software features.

Senior Governance & Control Specialist – Logical Access
Senior Governance & Control Specialist leading governance and control functions for TD Bank. Providing expert guidance and strategic direction to executive and functional stakeholders.

Customer Audit and Risk Analyst
Conduct audits and reviews of partner customers for compliance at zerohash while performing KYC screenings and due diligence in a remote role.

Analista de Governança Sênior
Senior IT Governance Analyst at EVT focusing on software support processes and continuous improvement. Join a collaborative team with a focus on IT governance and service management best practices.

Operational Risk Control Test Manager II, Governance & Control
Manager II in Governance & Control at TD responsible for leading a team in Operational Risk. Overseeing testing analysts to manage risks and ensure compliance across functions.

Senior Manager, Risk Analytics – Decision Science
Senior Manager, Risk Analytics & Decision Science at Greenbox Capital shaping credit strategies to optimize decision frameworks and improve model performance for small businesses' funding.

Risk Control Graduate Intern
Risk Control Graduate Summer Intern supporting analytics and reporting efforts at Liberty Mutual. Gaining hands-on experience in data management, dashboard development, and business-focused reporting.

Associate Director, Governance, Data Management Operations Enablement
Associate Director for Governance & Data Management Operations Enablement at IQVIA. Overseeing data governance, compliance, and operational efficiency for global data-driven products.

Associate Director, Research & Development, Data Governance
Associate Director leading R&D data governance initiatives within Johnson & Johnson MedTech. Focusing on data integrity and collaboration with cross-functional stakeholders across the organization.