Senior Consultant - MedTech QMS

Veeva Systems; United States; 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 seeks an experienced consultant to lead MedTech Complaints implementations for global customers. This role guides transformation of customers’ Complaints Management processes and technology within Veeva’s MedTech QMS solutions.

You will work with Professional Services to ensure delivery success across implementations, serving as the primary liaison among customers, teams, and third parties. Extensive GMP/consulting experience and regulatory knowledge are required.

Qualifications

• 8+ years of GMP systems ownership or software consulting.
• 5+ years of complaints management for medical devices.
• Strong understanding of FDA and EU MDR/IVDR requirements and reporting.
• Knowledge of ISO 13485 and 14971, FDA 21 CFR 803/820/822/806, EU GMP Annex 11.

Responsibilities

• Review and analyze existing customer business processes and identify key steps, gaps, and requirements affecting implementation.
• Lead QMS Complaints implementation workstreams for Veeva’s MedTech Quality Management solutions.
• Function as primary customer liaison among implementation teams, customer stakeholders, and third parties.
• Analyze customer requirements and new product features to develop adoption and enhancement roadmaps.
• Guide customers in adopting Vault and best practices as part of post-implementation programs.

Skills

GMP Systems ownership

Software Consulting

Complaints Management

FDA/EU MDR/IVDR knowledge

ISO 13485/14971 knowledge

SaaS understanding

Communication skills

Life Sciences experience

Tools

Veeva Vault

Job description

The Role
Veeva is looking for an experienced consultant to lead MedTech Complaints implementations at Veeva’s MedTech customers globally. This role will guide the transformation of our customers’ Complaints Management processes and technology. The MedTech Complaints consultant will work closely with Professional Services teams to ensure delivery success across QMS implementations.

What You\'ll Do

• Review and analyze existing Customer business process and identify key process steps, gaps, and requirements that would impact implementation approach
• Lead QMS Complaints 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

Requirements

• 8+ years of experience in GMP Systems ownership or Software Consulting
• 5+ years of experience in Complaints Management for Medical Device
• Strong understanding of FDA, EU MDR/IVDR requirements and Reporting
• Understanding of relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes
• Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11
• Proven track record leading implementation and/or IT operations as a consultant, business analyst, or IT lead and/or business sponsor
• Proven ability to work both independently and in teams in a dynamic, fast-moving environment
• Good understanding of SaaS and GxP principles
• Ability to quickly understand business requirements and design creative solutions
• Excellent verbal and written communication skills
• Experience in the Life Sciences Quality, Manufacturing, or Healthcare spaces
• Experience with Data or Content Management applications

Nice to Have

• Veeva Vault implementation experience
• Management Consulting
• Change Management experience
• Field Action and Product Return experience
• Clinical Medical Device, Biologics, and SaMD experience

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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’s headquarters 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 [e-mail].