Radformation is hiring a
Risk Management Specialist

Summary

Radformation is hiring a Risk Management Specialist to join their team and help improve Risk Management strategies and processes. The specialist will be responsible for developing and executing risk management plans, maintaining product risk files, and evaluating proposed products for risk significance. They will also assist in the preparation of regulatory submissions and impact assessments, and facilitate FMEA/FMECA activities. Radformation requires 5+ years of Risk Management experience, including software in an Agile or SAFE environment, and 3+ years of medical device requirements management and traceability for software products. Preferred experience includes radiation oncology clinical experience, software application development, machine learning, NLP, algorithm development, and remote work experience. Radformation offers top-tier medical, dental, vision care, stock options, a 401(k) with employer match, self-managed PTO, generous parental leave, and support for remote work.

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 Quality Management Systems, QMS, 21 CFR 820 and ISO 13485 and 14971
• Experience with industry standards 14971, 62304 and 82304 industry standards
• Experience with Requirement Quality and Defect Prevention Techniques
• 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

Responsibilities

• 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 products for Risk Significance
• Evaluate and interpret related Industry Standards
• 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

Preferred Qualifications

• 5+ years of Radiation Oncology, Clinical Experience
• 3+ years of Software Application Development
• Experience with Machine Learning, NLP and/or Algorithm development
• Experience working productively in a remote work setting and culture

Benefits

• Top-tier medical, dental, vision care for employees and their families
• Stock options for US-based employees only
• 401(k) & employer match
• Self-managed PTO
• Generous parental leave
• Fully remote team
• Virtual events, yearly retreats and a collaborative work environment