MedTech Regulatory RIM Implementation Lead — Remote

Veeva Systems, Inc.; Boston (MA); Hybrid; USD 80,000 - 200,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Flexible PTO

Paid holidays

Retirement programs

Charitable giving program

Job summary

Veeva Systems is seeking an experienced MedTech Regulatory Information Management (RIM) consultant to lead implementation workstreams globally. You will guide transformation of Regulatory Affairs and Operations using industry-leading technology, collaborating with Professional Services to ensure end-to-end delivery.

Responsibilities include analyzing current processes, bridging communication among teams and customers, and shaping adoption roadmaps.

Qualifications

• 8+ years of experience in Systems Implementation, GxP Systems ownership, or Software Consulting.
• 4+ years of experience in Regulatory Operations or Regulatory Affairs in Medical Devices or Diagnostics.
• Direct experience with software implementations for RIM or similar solutions (e.g. RegDesk, RIMSYS, IQVIA, Kalypso, Essenvia).
• Strong understanding of global regulatory requirements including FDA, EU MDR/IVDR, Technical Documentation structures and UDI reporting.

Responsibilities

• Lead RIM implementation workstreams for MedTech Regulatory solutions and ensure successful customer adoption.
• Review and analyze existing customer processes to identify gaps and requirements for implementation.
• Serve as primary customer liaison, managing communication between teams, stakeholders and third parties.
• Analyze customer requirements and new features to develop long-term adoption roadmaps for Regulatory Operations.
• Guide customers in adopting Veeva RIM and best practices for regulatory data and document management.

Skills

Regulatory operations

Regulatory affairs

Consulting

Communication

Stakeholder management

Requirements analysis

Tools

Veeva RIM

RegDesk

RIMSYS

IQVIA

Kalypso

Essenvia

Job description

Veeva Systems is seeking an experienced MedTech Regulatory Information Management (RIM) consultant to lead implementation workstreams globally. You will guide transformation of Regulatory Affairs and Operations using industry-leading technology, collaborating with Professional Services to ensure end-to-end delivery.

Responsibilities include analyzing current processes, bridging communication among teams and customers, and shaping adoption roadmaps.