Medical Device International RA Specialist

Boston, MA

Job ID: 132633 Industry: Regulatory & Scientific

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. 

Duties/Responsibilities:
  • 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

Required:
  • Medical Device
  • Global Regulatory Affairs
  • Technical File Remediation
  • Global Product Registrations
  • Minimum Bachelors Degree

Preferred:
  • EU MDR Experience
  • Bachelors Degree in a Scientific or Engineering Field 

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