Data Specialist, Medical Devices

GForce Life Sciences; Gainesville (FL); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Job summary

A Fortune 500 medical device company is seeking a Consultant, UDI Data/Validation Analyst to drive compliance with global regulations. The ideal candidate will have extensive experience in data analysis and a solid understanding of UDI standards. This position involves collaborating across teams and leading projects to ensure timely regulatory compliance in Jacksonville, FL. This is a full-time position lasting over 12 months with benefits included.

Qualifications

• 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.

Responsibilities

• Perform data, technology, and business activities that drive UDI compliance.
• Lead selected projects and work with IT on required system improvements.
• Collaborate with new product teams to meet UDI and eligibility requirements.

Skills

Data analysis

Data mining

Project management

Regulatory compliance

Problem-solving

Education

Bachelor’s degree

Advanced degree

Job description

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)

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance, Analyst, and Information Technology

Industries

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