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Newark, DE 19713
Position Title: Risk Manager
Position Number: 308630
Location: Newark, DE
Desired Skill Set:Compliance, FDA, ISO 13485, Medical device, MS Excel, Regulatory Affairs, Risk Analysis, Risk Management, SAP
Position Description:C2C is not available
Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.Job Title: Risk Management Consultant
Location: Newark, DE 19702
Duration: 12+ Months, potential to go permanent
Schedule: Shift 1; M-F (8:00 AM – 4:30 PM)
Principle Duties and Responsibilities:
· This position supports the timely implementation of In Vitro Diagnostic Regulation (IVDR) risk documents. These documents need to be remediated, or created according to the program implementation schedule.
· This individual will be responsible for gathering documentation related to our Risk Management Files, reviewing risk documents for compliance, and remediating/recreating risk documentation as necessary. The IVDR Risk Management Consultant will be responsible for updating and/or creating new dFMEA’s and pFMEA’s from scratch, writing Risk Plans, Risk Reports, Performance Evaluation Report Statements, and Post Market Surveillance Report Conclusion Statements.
· The Risk Management Consultant will also work with R&D and Manufacturing groups on FMEA Remediation, as well as with Post Market Surveillance and Clinical Affairs groups to assess Overall Residual Risk and Risk-Benefit analysis as needed. There will likely be additional cross-functional support required in creating/optimizing Product Family Groups to encourage project efficiency. This individual will be responsible for executing risk documentation deliverables within an already created Risk Management Template.
· This individual must be comfortable in a hands-on role, with strong experience in Risk Management (ISO 14971:2012), 21 CFR Part 820, Design Controls, Risk Controls, dFMEA & pFMEA review/remediation/creation, Risk Classifications, Post-Market Risk Management, Clinical Risk-Benefit Analysis, Root Cause Analysis, and Change Control/Design Changes. This IVDR Risk Management Consultant should also have experience using SAP to identify and manage the documentation.
· EU IVDR or EU MDR project-experience would be a plus, and experience using Documentum would be a huge plus (experience with similar Electronic Document Management Systems will suffice).
· Bachelor of Science in Engineering, and at least 5 years’ experience in medical devices and / or diagnostics industry as a risk management professional
· ISO 13485:2016
· Risk Management (ISO 14971:2012)
· dFMEA & pFMEA (Identify/Review/Remediate/Rewrite)
· Design Changes & Design Changes (21 CFR Part 820)
· Risk Classifications & Risk Controls
· Post-Market Risk / Clinical Risk Benefit-Analysis
· MS Excel
· Experience using Electronic Document Management Systems
· IVD/Assay Product Experience
· EU IVDR or EU MDR Project Experience
· Familiarity with SAP, Team Center and Documentum
· This is a one year contract with the possibility to extend.#CBRose#
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Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.
Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify).
(Posting required by OCGA 13/10-91.)