Risk Management Specialist
Remote US / Remote Canada
Regulatory – Regulatory /
Full-Time /
Remote
Radformation is seeking a self-motivated Risk Management Specialist to join an innovative team. As Radformation sets out to scale, the Risk Management Specialist will work directly with the VP of Regulatory Affairs and our VP of Product to:
- 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
As Radformation believes that requirement quality is a key contributor to defect and risk prevention this position is also tasked with improving the quality characteristics of product requirements, establishing clear, conscious non-ambiguous requirements that map to use cases, are understood by all stakeholders, and or objectively verifiable.
Risk Management is a multidimensional discipline. As part of a smaller team environment, you will have the opportunity to learn and work through all aspects of the Risk Management and Requirements Management professions. We require that you are coachable and have the drive to become a leader in the Risk Management profession.
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
Required Experience
- 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.
Preferred Experience
- 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
$135,000 - $175,000 a year
Salary listed is in USD for US-based employees and will be commensurate with experience. Salary range will vary for international candidates and be commensurate with experience and geographical location.
