Jobless Developer
V
Veeva

Posted 2 months ago

Open

Senior Consultant - MedTech Regulatory Implementation

PhiladelphiaRemoteFull-time

AI Summary

Senior Consultant leading MedTech Regulatory Information Management (RIM) implementations for Veeva’s global MedTech customers, guiding regulatory processes and ensuring successful system adoption.

About this role

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead.
At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.
As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.
Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.

The Role

Veeva is looking for an experienced consultant to lead MedTech Regulatory Information Management (RIM) implementations at Veeva’s MedTech customers globally. This role will guide the transformation of our customers’ Regulatory Affairs and Operations processes through industry-leading technology. The MedTech Regulatory consultant will work closely with Professional Services teams to ensure delivery success across the end-to-end regulatory process, covering both data and documentation related workstreams.

What You'll Do

  • 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

    • Nice to Have

  • 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

    • Perks & Benefits

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

    • Compensation

  • Base pay: $80,000 - $200,000
  • The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus.

    • Skills

    Change ManagementEssenviaEU MDRFDAGxP SystemsIQVIAIVDRKalypsoRegDeskRegulatory Information Management (RIM)RIMSYSUDIVeeva RIMVeeva Vault

    Explore related jobs

    More jobs at Veeva

    Similar Change Management jobs

    Jobs in Philadelphia

    Browse these categories

    Change Management JobsJobs in PhiladelphiaJobs in United States