Senior Consultant - MedTech Regulatory Implementation

Veeva Systems, Inc.; San Francisco (CA); Remote; USD 80,000 - 200,000; Full time

Benefits offered by this job

Medical, dental, vision, and basiclife

Flexible PTO and holidays

Retirement programs

1% charitable giving program

Job summary

Veeva Systems seeks an experienced MedTech Regulatory Information Management consultant to lead RIM implementations for global customers. You will guide transformation of Regulatory Affairs and Operations processes through industry-leading technology, collaborating with Professional Services to ensure end-to-end delivery.

The role requires deep knowledge of regulatory requirements (FDA, EU MDR/IVDR), data and documentation workstreams, and strong stakeholder management.

Qualifications

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

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 continuous improvement of Regulatory data and document management.

Skills

Systems Implementation

GxP Systems ownership

Software Consulting

Regulatory Operations

Regulatory Affairs

Veeva RIM

Global regulatory knowledge

IT leadership / project leadership

Communication skills

Tools

Veeva Vault

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.

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

Interviewing with Veeva

We value your time and believe in a transparent hiring process. Here is the process you can expect.

• Within 3 days, you will receive a link to a personality assessment administered by a third party.
• Once you complete the assessment, our team will review your full application package and follow up via email with our decision.
• If moving to the interview stage, the process is as follows:
  1. A conversation with the hiring manager
  2. A practical case exercise
  3. A final conversation with our group's Senior Leader.
• Once all interviews are complete, the manager will be in touch with a final decision.

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.

Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.

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].