Senior Consultant - MedTech Regulatory Implementation

About the role

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.

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.

Requirements

• 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 (e.g. 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.
• Direct Veeva Vault implementation experience.
• Experience with Change Management and Management Consulting.
• Experience with MedTech products or Medical Devices, In-Vitro Diagnostics, Software as a Medical Device (SaMD) or combination products.
• Experience with UDI (Unique Device Identification) or global submission planning.

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 (e.g. 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.
• Direct Veeva Vault implementation experience.
• Experience with Change Management and Management Consulting.
• Experience with MedTech products or Medical Devices, In-Vitro Diagnostics, Software as a Medical Device (SaMD) or combination products.
• Experience with UDI (Unique Device Identification) or global submission planning.

Skills

• 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.
• Direct Veeva Vault implementation experience.
• Experience with Change Management and Management Consulting.
• Experience with MedTech products or Medical Devices, In-Vitro Diagnostics, Software as a Medical Device (SaMD) or combination products.
• Experience with UDI (Unique Device Identification) or global submission planning.

Benefits

• Medical, dental, vision, and basic life insurance
• Flexible PTO and company paid holidays
• Retailer retirement programs
• 1% charitable giving program

Pay

Base pay: $80,000 - $200,000

Schedule

Commutes to office as needed.

Company

A different kind of company. A Public Benefit Corporation.

Company Values

• Do the right thing
• Customer success
• Employee success
• Speed

Equal Opportunity Employer

Veeva is committed to providing equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, national origin, age, disability, veteran status, genetic information, sexual orientation, gender identity or expression, or any other characteristic protected by law. We are proud to be an equal opportunity employer.