Medical Device International RA Specialist
RA Specialist x3 (EU MDR)
Scope of Work:
Our client is a large Medical Device organization that manufactures Class II & Class III Medical Devices. They are currently in need of a RA Specialist to support the client’ s EU MDR project, specifically in remediating Technical Files and supporting Global Product Registrations updates.
- Assess Technical Files compliance status and develop Remediation plan.
- Create, maintain and execute remediation of Technical Files.
- Be the primary resource to generate and maintain common product technical documents to support global product registrations.
- Collaborate cross-functionally with regional Regulatory Affairs stakeholders to support updates to global registrations & global product re-classifications.
- Provide necessary information/data on Post-Market product changes.
- Maintain country specific registration requirements
- Maintain electronic databases to ensure accurate data
- Collaborate with client' s regional/country RA teams to collect required documents upon fully understanding the local regulations for registration.
- Act as liaison between regional/country RAs and BU corporate cross-functions to address questions and issues arising during local government reviews and/or tests.
- Maintain and update electronic RA systems (used for tracking Worldwide Product Registrations) to ensure the accuracy of the product and project status.
- Obtaining/Maintaining Certificates of Foreign Government (CFG)/Certificates of Free Sale (CFS)
- Provide information in support of customer queries, bid and tender submission, customs queries, etc.
- Support management on creating and maintaining relevant RA policies and procedures
- Medical Device
- Global Regulatory Affairs
- Technical File Remediation
- Global Product Registrations
- Minimum Bachelors Degree
- EU MDR Experience
- Bachelors Degree in a Scientific or Engineering Field