Peak Performers · 2 days ago
Risk Management (Subject Matter Expert)
Mansfield, MA
Contract
Hybrid
Senior Level
$99.93/hr - $99.93/hr
5+ years expPeak Performers has partnered with a global pharmaceutical company to assist in their search for a hybrid Risk Management SME. In this contract position, you will be responsible for performing gap assessments, planning, organizing, executing, and reporting all usability and risk management activities through collaboration with cross functional teams.
Human ResourcesEmployment
No H1B
Responsibilities
Perform thorough gap assessment of existing usability and risk management documentation against EU MDR requirements and relevant standards, such as ISO 14971:2019 and IEC 62366-1:2015
Provide risk management leadership, expertise, guidance, and supervision throughout the remediation project
Development of efficient and robust processes, procedures, practice, tools and technology to support continuous improvement in risk management
Leads development and implementation of key performance indicators and metrics for the risk management process
Support the post market surveillance team by creating Health Impact Assessments and Health Hazard Evaluations
Qualification
Required
Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical, Electrical)
5-7 years of experience of working within a medical device industry with subject matter expertise in the application of Risk Management (ISO 14971:2019) for all classes of medical devices
Expertise in the application of statistical techniques to support the calculation of probabilities of hazardous situations occurring (p1)
Expertise in industry best practices and advances in Usability Engineering and Risk Management practices, processes, tools and technology
Benefits
Excellent medical health, dental & vision insurance at 60 days
Our employees may choose to participate in a 403(b) retirement plan
Company
Peak Performers
PEAK PERFORMERS is a temporary employment firm.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Bree Sarlati
Chief Executive Officer
Michael Sergi
Chief Financial Officer
Company data provided by crunchbase