Medical Device Risk Management Advisor

Job not on LinkedIn

🕒 February 18

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Logo of FocusKPI, Inc.

FocusKPI, Inc.

11 - 50 employees

Founded 2010

🤖 Artificial Intelligence

Consulting • Artificial Intelligence • Data Analytics

FocusKPI, Inc. is a company that specializes in delivering high return on investment (ROI) results at scale through data analytics and machine learning. With over ten years of consulting experience, FocusKPI offers custom-built services to help businesses drive revenue and save costs. The company's core offerings include data analytics and machine learning services, enterprise AI products aimed at improving business operating efficiency, and staffing and recruiting services that provide high-quality talent with high retention rates. FocusKPI helps global brands achieve productivity and ROI improvements and is praised for providing high-quality and competitive services comparable to big-name companies. They integrate their solutions flexibly with common platforms such as data warehouse, public data, and CRM systems.

📋 Description

• 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

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