67 applicants
Radformation · 3 days ago
Risk Management Specialist
United States
Full-time
Remote
Senior Level
$135K/yr - $175K/yr
5+ years exp
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Responsibilities
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
Qualification
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Required
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 Management Systems, Quality Management Systems, MDSAP, 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.
Preferred
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
Medical, Dental, Vision Care
401(k) & Employer Match
Self-managed PTO
Generous Parental Leave
Part-time Work Options
Fully Remote Team
Virtual Events
Yearly Retreats
Inclusive Environment
Equal Opportunity Workplace
Company
Radformation
Radformation helps cancer patients receive treatment faster with safer, smarter radiation treatment plans.
51-200 employees
Funding
Current Stage
Early StageTotal Funding
$8.46MKey Investors
Brooklyn Bridge Ventures
2023-05-25Series Unknown· $6.86M
2019-10-09Seed· Undisclosed
2018-06-12Seed· $1.6M
Leadership Team
Alan Nelson
Co-Founder & CSO
Elisabeth Van Wie Van Wie
Medical Physicist and Chief Business Officer
Recent News
2024-05-01
2024-02-11
Company data provided by crunchbase
