MedTech Regulatory RIM Lead for Global Implementations

Veeva Systems, Inc.; Philadelphia (Philadelphia County); Remote; USD 80,000 - 200,000; Full time

Benefits offered by this job

Medical, dental, vision, and basiclife

Flexible PTO and company paid holidays

Retirement programs

1% charitable giving program

Job summary

Veeva Systems, Inc. is seeking an experienced MedTech Regulatory Information Management (RIM) consultant to lead implementations across global customers.

You will guide regulatory operations transformations, collaborating with Professional Services to ensure end-to-end delivery of data and documentation workstreams. You will manage RIM adoption, analyze current processes, and develop strategic roadmaps for regulatory operations while advocating best practices in regulatory data and document

Qualifications

• 8+ years of experience in Systems Implementation, GxP Systems ownership, or Software Consulting.
• 4+ years of experience working with or in Regulatory Operations or Regulatory Affairs specifically within the Medical Device or Diagnostics industry.
• Direct experience with software implementation for Veeva RIM or similar solutions (RegDesk, RIMSYS, IQVIA, Kalypso, Essenvia).
• Strong understanding of global regulatory requirements, including FDA, EU MDR/IVDR, Technical Documentation structures and UDI reporting standards.
• Proven track record leading IT operations or implementations as a consultant, business analyst, or business sponsor.
• Excellent verbal and written communication skills, with the ability to design creative solutions for complex business requirements.

Responsibilities

• Lead RIM implementation workstreams for Veeva’s MedTech Regulatory solutions, ensuring successful customer adoption and system configuration.
• Review and analyze existing customer business processes to identify key process steps, gaps, and requirements that impact the implementation approach.
• Function as a primary customer liaison, managing complex communication between implementation teams, customer stakeholders, and third parties.
• Analyze customer requirements and new product features to develop long-term adoption and enhancement roadmaps for Regulatory Operations.
• Guide customers in adopting Veeva RIM and industry best practices, focusing on the continuous improvement of Regulatory data and document management.

Skills

Regulatory Operations

Regulatory Affairs

GxP Systems ownership

Software Consulting

Communication skills

Stakeholder management

Tools

Veeva RIM

RegDesk

RIMSYS

IQVIA

Kalypso

Essenvia

Job description

Veeva Systems, Inc. is seeking an experienced MedTech Regulatory Information Management (RIM) consultant to lead implementations across global customers.

You will guide regulatory operations transformations, collaborating with Professional Services to ensure end-to-end delivery of data and documentation workstreams. You will manage RIM adoption, analyze current processes, and develop strategic roadmaps for regulatory operations while advocating best practices in regulatory data and document