Senior Consultant - MedTech Regulatory Implementation

Veeva; Chicago (IL); On-site; USD 80,000 - 200,000; Full time

Benefits offered by this job

Medical, dental, vision, and life insurance

Flexible PTO and company paid holidays

Retirement programs

1% charitable giving program

Job summary

Veeva Systems, based in Chicago, is seeking an experienced consultant to lead MedTech Regulatory Information Management (RIM) implementations. This role involves guiding customers through Regulatory Affairs and Operations processes with industry-leading technology.

Applicants should have over 8 years of experience in Systems Implementation and strong knowledge of global regulatory requirements. The position offers a hybrid work environment and a range of benefits including flexible PTO and retirement programs.

Qualifications

• 8+ years of experience in Systems Implementation, GxP Systems ownership, or Software Consulting.
• 4+ years of experience in Regulatory Operations or Regulatory Affairs within the Medical Device or Diagnostics industry.
• Direct experience with software implementation for Veeva RIM or similar solutions.

Responsibilities

• Lead RIM implementation workstreams for MedTech Regulatory solutions.
• Review and analyze existing customer business processes.
• Function as a primary customer liaison managing complex communication.

Skills

Systems Implementation

Regulatory Operations

Consulting

Change Management

Communication

Tools

Veeva RIM

RegDesk

RIMSYS

IQVIA

Kalypso

Essenvia

Job description

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.

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.

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

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

Benefits

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

Salary

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. Actual salaries may vary within the range above or below, depending on experience and location. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus.

Equal Employment Opportunity Statement

Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at [e-mail].