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Senior Consultant - MedTech Regulatory Implementation

Veeva Systems · Philadelphia, PA · 1 wk ago
RemoteRemoteConsulting$80k–$200k/yrFull-time

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

  • Master’s degree in a relevant field (e.g., Computer Science, Information Technology, Biomedical Engineering, etc.)
  • Ability to manage multiple projects simultaneously and meet deadlines
  • Experience with project management tools and methodologies (e.g., Agile, Scrum)
  • Knowledge of regulatory compliance and industry standards
  • Strong analytical and problem-solving skills
  • Ability to communicate effectively with cross-functional teams

Skills

  • Systems Implementation
  • GxP Systems Ownership
  • Software Consulting
  • Regulatory Operations
  • Regulatory Affairs
  • MedTech Products
  • Medical Devices
  • In-Vitro Diagnostics
  • Software as a Medical Device (SaMD)
  • Combination Products
  • Global Regulatory Requirements
  • Change Management
  • Management Consulting
  • UDI (Unique Device Identification)
  • Project Management

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

Full-time, remote work

Company

Veeva is a Public Benefit Corporation (PBC), committed to helping make the industries we serve more productive and creating high-quality employment opportunities. We are a Public Benefit Corporation (PBC), which means we consider our public benefit purpose and the interests of those materially affected by the corporation’s conduct—including customers, employees, and the community—in addition to shareholders’ interests. We are a Public Benefit Corporation (PBC), which means we consider our public benefit purpose and the interests of those materially affected by the corporation’s conduct—including customers, employees, and the community—in addition to shareholders’ interests. We are a Public Benefit Corporation (PBC), which means we consider our public benefit purpose and the interests of those materially affected by the corporation’s conduct—including customers, employees, and the community—in addition to shareholders’ interests.

Location

Veeva has product hubs in Pleasanton, Columbus, Boston, Kansas City, New York City, Raleigh, and Toronto. Customer-facing roles, such as Sales and Professional Services, live near and/or travel to their customers.

Equal Opportunity Employer

Veeva is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status, or any other characteristic protected by law. We are committed to providing a workplace free from discrimination and harassment, and we are dedicated to fostering a diverse and inclusive workforce.

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