Data Specialist, Medical Devices

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)

Mid-Senior level

Full-time

Quality Assurance, Analyst, and Information Technology

Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Data Infrastructure and Analytics