Skills

Data Mining SAP Change Management Data collection Project Management

Job Specifications

Consultant, UDI Data/Validation Analyst, Medical Devices

Summary

Our client, a Fortune 500 medical device company, has engaged GForce Life Sciences to provide a Data Analyst. The Data Analyst – Global UDI will coordinate and perform data collection with NPI teams to meet EUDAMED and FDA requirements, coordinate and perform data collection in all required formats based on health authority requirements (spreadsheet, machine-to-machine, etc.), provide analytical, planning and project management support for selected US and international regulatory and customer contractual compliance projects related to UDI/GDSN. The Data Analyst will assess system capabilities and collaborate with IT on data modeling, system innovation and implementation to achieve timely compliance and scalable solutions for future regulations.

Responsibilities

Perform data, technology, and business activities that drive UDI compliance to Global regulations.
Lead selected projects within this area.
Work with IT on required system improvements. Actively recommend process / system improvements, and lead implementation including change management.
Collaborate with new product teams to meet UDI and eligibility requirements; complete supporting requests and documentation that will set up eligibility requirements for SAP.
Ensure timely implementation and conformance with regulations as well as company policies and values.
Develop solutions, identify risks, run scenarios, and make contingency plans with other cross functional team members.
Build trust-based cross functional partnerships.
Work cross functionally to develop new processes and SOPs and train key personnel on them.
Stay on top of new/existing UDI regulations within the U.S. and published/upcoming regulations for other countries.
Continually assess impact of changes to the end customer.
Always apply a quality and compliance mindset.
Conduct data analyses, reporting and processing through multiple systems.

Requirements

Bachelor’s degree required and advanced degree is preferred
Minimum of 6 years of relevant experience required
Minimum of 3 years in data analyses/data mining required
Previous experience working in a regulated industry required
Experience with UDI, GS1 standards including GDSN

Nice to Have

Experience with UDI, GS1 standards including GDSN
Minimum of 3 years project management experience preferred
Experience in system design/data modeling highly preferred

Terms & Start

Onsite in Jacksonville, FL
12+ month contract
Start ASAP
Benefits included (Medical, Dental, Vision)

About the Company

- Multi-Year Award Winner Inc. 5000's America's Fastest Growing Companies - Awarded Best Places to Work in IL every year from 2018-present - Multi-Year Award Winner "Best Staffing Firm to Work For" by Staffing Industry Analysts - Awarded Best of Staffing - Talent Satisfaction by ClearlyRated from 2019-present GForce Life Sciences matches highly targeted consultants and direct hire candidates to executives' needs. Regulatory pressures, altering market demands and healthcare refinement are changing the landscape of the glo... Know more