Risk Management Specialist

April 20

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Intelligent Automation in Cancer Care

Treatment plan evaluation • Automated treatment planning • Eclipse scripting

51 - 200

💰 Seed Round on 2019-10

Description

• Develop and execute Risk Management strategies • Improve the Risk Management processes • Compile regulatory submissions • Maintain Master Harms Registry • Develop and Maintain Product Risk Files • Own Creation and Maintenance of Risk Reports and Risk Benefit Assessments • Evaluate proposed product for Risk Significance • Evaluate and interpret related Industry Standards

Requirements

• 5+ years of Risk Management Experience, including Software in an Agile or SAFE environment • 3+ years of Medical Device Requirements Management and Traceability for Software Products • Experience with nagement Systems, Quality MaMDSAP, 21 CFR 820 and ISOs 13485 and 14971 • Experience with industry standards 14971, 62304 and 82304 industry standards • Experience with Requirement Quality and Defect Prevention Techniques • Experience with test protocols and verification of product risk controls • Highly motivated • Strong analytical skills • Passionate about learning • Excellent communication and interpersonal skills • The ability to think strategically, multi-task, and meet deadlines • The ability to coach constructively and lead by influence.

Benefits

• Assist in the preparation of regulatory submissions and impact assessments. • Facilitate Product, Process and User FMEA\FMECA activities • Lead product development teams in the creation of Software Fault Tree and SW hazard analysis deliverable creation • Own Product Risk Files and Annual Maintenance Deliverables • Author Product Risk Reports and Risk Benefit Analysis • Manage Risk Related Product Requirements  • Own Risk Mitigation Verification of Effectiveness • Comply with the Quality Management System and ISO 14971:2019+AN 2020 • Facilitate Product Safety Risk \ Hazard Evaluations in Support of Post Market Surveillance & Event Reporting • Provide technical review of data and reports • Update Clinical Evaluation Reports on an annual basis with latest Risk File updates • Assist Project Teams with Requirement Management and traceability functions • Work with product teams on Requirement Quality Attributes • Conduct Product Requirement  Design Reviews and Propose Improvements • Establish requirement based preventative measures that focus on requirement characteristics, traceability and failure analysis. • Work closely with the team to identify and mitigate foreseeable misuse