MedTech Regulatory Consultant

New

Skills

Business Analysis EU MDR/IVDR FDA Regulations GxP Systems Regulatory Affairs Regulatory Information Management (RIM) Regulatory Operations Software Implementation UDI Compliance Veeva RIM

As a Senior Consultant specializing in MedTech Regulatory Implementation, you will lead the implementation of Regulatory Information Management (RIM) solutions tailored to the medical technology industry. You will play a crucial role in analyzing customer processes, identifying gaps, and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Lead RIM implementation workstreams for MedTech regulatory solutions.
  • Review customer processes to identify steps, gaps, and requirements.
  • Serve as the primary customer liaison and manage communications among teams.
  • Analyze requirements and features to develop adoption roadmaps for Regulatory Operations.
  • Guide customers in adopting Veeva RIM and best practices for regulatory data and documentation.
Required Skills & Qualifications
  • 8+ years of experience in Systems Implementation, GxP Systems ownership, or Software Consulting.
  • 4+ years in Regulatory Operations or Regulatory Affairs in Medical Device/Diagnostics.
  • Direct experience with software implementation for Veeva RIM or similar solutions.
  • Strong understanding of global regulatory requirements including FDA, EU MDR/IVDR, and UDI.
  • Proven track record leading IT operations or implementations as a consultant, business analyst, or sponsor.
  • Excellent verbal and written communication skills.
  • Able to design creative solutions for complex requirements.

No forms. Your profile is generated instantly.

Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: Months

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