Senior Consultant - Medtech QMS Complaints (Fully Remote)

Veeva Systems; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

Veeva Systems seeks an experienced consultant to lead MedTech Complaints implementations for its global customers. You will guide the transformation of customers’ Complaints Management processes and technology as part of the Professional Services team.

Responsibilities include reviewing customer processes, leading QMS Complaints workstreams, and aligning requirements with FDA/EU MDR/IVDR and ISO 13485/14971 to drive adoption and product enhancements for our life sciences clients.

Qualifications

• 5+ years leading consulting implementations in Complaints Management for Medical Device.
• Strong understanding of FDA, EU MDR/IVDR requirements and ISO 13485/14971.
• Good grasp of SaaS and GxP principles and ability to translate requirements into solutions.

Responsibilities

• Review and analyze existing customer business processes and identify gaps and requirements.
• Lead QMS Complaints implementation workstreams and act as primary customer liaison.
• Analyze requirements and product features to develop adoption and enhancement roadmaps.

Skills

Complaints Management

MedTech

QMS

Regulatory Awareness

SaaS Understanding

Job description

• Veeva is looking for an experienced consultant to lead MedTech Complaints implementations at Veeva’s MedTech customers globally.
• Guide the transformation of customers’ Complaints Management processes and technology as a member of the Professional Services team.
• Ideal for a proven software consultant with deep knowledge in Complaints Management in Medical Device.

What You’ll Do:

• Review and analyse existing customer business process and identify key process steps, gaps, and requirements.
• Lead QMS Complaints implementation workstreams and function as primary customer liaison.
• Analyse customer requirements and new product features to develop customer adoption and enhancement roadmaps.

Requirements:

• Proven track record leading implementation as a consultant with 5+ years in Complaints Management for Medical Device.
• Strong understanding of FDA, EU MDR/IVDR requirements and knowledge of ISO 13485 and 14971.
• Good understanding of SaaS and GxP principles and ability to quickly understand business requirements.

Veeva Systems is a mission-driven industry cloud pioneer that helps life sciences companies bring therapies to patients faster. The company surpassed $3B in revenue and has a culture built on Do the Right Thing, Customer Success, Employee Success, and Speed.