Senior Consultant - MedTech Regulatory Implementation
Illinois - Chicago Full-time $80,000 - $200,000 USD per year
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 workstreamsfor Veeva’s MedTech Regulatory solutions, ensuring successful customer adoption and system configurationReview and analyze existing customer business processesto identify key process steps, gaps, and requirements that impact the implementation approachFunction as a primary customer liaison, managing complex communication between implementation teams, customer stakeholders, and third parties
Analyze customer requirementsand new product features to develop long-term adoption and enhancement roadmaps for Regulatory OperationsGuide customers in adopting Veeva RIMand industry best practices, focusing on the continuous improvement of Regulatory data and document management
Requirements
8+ years of experiencein Systems Implementation, GxP Systems ownership, or Software Consulting4+ years of experience working with or in Regulatory Operations or Regulatory Affairsspecifically within the Medical Device or Diagnostics industryDirect experience with software implementationfor 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 recordleading IT operations or implementations as a consultant, business analyst, or business sponsorExcellent 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.
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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 talent_accommodations@veeva.com.
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