Global MedTech QMS Implementation Lead — Remote

Lever, Inc.; Boston (MA); Remote; USD 80,000 - 200,000; Full time

Benefits offered by this job

Medical, dental, vision, and basiclife

Flexible PTO and company holidays

Retirement programs

1% charitable giving program

Job summary

Veeva Systems is a mission-driven organization enabling life sciences leaders to transform how they bring therapies to patients. The MedTech Quality consultant will drive QMS implementations globally, partner with Professional Services, and guide customers in adopting Vault and best practices for post-implementation success.

The role requires 6+ years in GMP systems or software consulting, deep regulatory knowledge (FDA/EU MDR/IVDR), and strong communication in a fast-paced SaaS environment.

Qualifications

• 6+ years of experience in GMP Systems ownership or Software Consulting.
• Strong understanding of FDA, EU MDR/IVDR requirements and Reporting.
• Understanding of Complaint Handling, CAPA, Nonconformance and Risk Management.
• Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11.

Responsibilities

• Review and analyze existing Customer business process and identify key process steps, gaps, and requirements that would impact implementation approach
• Lead QMS implementation workstreams at our customers for Veeva’s MedTech Quality Management solutions
• Function as a Primary customer liaison managing communication between implementation teams, customer stakeholders, and 3rd parties
• Analyze customer requirements and new product features to develop customer adoption and enhancement roadmaps
• Guide customers in adopting Vault and industry best practices as part of post-implementation programs focused on the holistic success and continuous improvement of the customer

Skills

GMP Systems ownership

Software Consulting

Regulatory knowledge (FDA/EU MDR)

Quality Management / QMS experience

Life Sciences domain

Excellent communication

Veeva Vault

Tools

Veeva Vault

Job description

Veeva Systems is a mission-driven organization enabling life sciences leaders to transform how they bring therapies to patients. The MedTech Quality consultant will drive QMS implementations globally, partner with Professional Services, and guide customers in adopting Vault and best practices for post-implementation success.

The role requires 6+ years in GMP systems or software consulting, deep regulatory knowledge (FDA/EU MDR/IVDR), and strong communication in a fast-paced SaaS environment.