Newark, United States
4 months ago
This position supports the timely implementation of In Vitro Diagnostic Regulation (IVDR) risk documents. These documents need to be remediated and recreated 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 dFMEAs and pFMEAs 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.
Position requires experience with:
- 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 System
- 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.
- Reliable and capable of working with minimal supervision to lead/manage large cross-departmental projects.
- Able to manage controversial issues that may arise through constructive communication with cross-functional teams.
- Highly compliance-oriented to firmly adhere to the principles of the regulations and standards.