Remote MedTech Regulatory Implementation Lead

Veeva Systems, Inc.; San Francisco (CA); Remote; USD 80,000 - 200,000; Full time

Benefits offered by this job

Medical, dental, vision, and basiclife

Flexible PTO and holidays

Retirement programs

1% charitable giving program

Job summary

Veeva Systems seeks an experienced MedTech Regulatory Information Management consultant to lead RIM implementations for global customers. You will guide transformation of Regulatory Affairs and Operations processes through industry-leading technology, collaborating with Professional Services to ensure end-to-end delivery.

The role requires deep knowledge of regulatory requirements (FDA, EU MDR/IVDR), data and documentation workstreams, and strong stakeholder management.

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 Device or Diagnostics industries.
• 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 continuous improvement of Regulatory data and document management.

Skills

Systems Implementation

GxP Systems ownership

Software Consulting

Regulatory Operations

Regulatory Affairs

Veeva RIM

Global regulatory knowledge

IT leadership / project leadership

Communication skills

Tools

Veeva Vault

RegDesk

RIMSYS

IQVIA

Kalypso

Essenvia

Job description

Veeva Systems seeks an experienced MedTech Regulatory Information Management consultant to lead RIM implementations for global customers. You will guide transformation of Regulatory Affairs and Operations processes through industry-leading technology, collaborating with Professional Services to ensure end-to-end delivery.

The role requires deep knowledge of regulatory requirements (FDA, EU MDR/IVDR), data and documentation workstreams, and strong stakeholder management.