Note: The job is a remote job and is open to candidates in USA. Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. They are seeking an experienced consultant to lead MedTech Regulatory Information Management implementations, guiding customers through the transformation of their Regulatory Affairs and Operations processes using Veeva’s technology.
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
- 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
Benefits
- Medical, dental, vision, and basic life insurance
- Flexible PTO and company paid holidays
- Retirement programs
- 1% charitable giving program
Company Overview
Company H1B Sponsorship