IT Business Analyst

Dignifyd; Mundelein (IL); On-site; USD 110,000 - 160,000; Full time

Job summary

Dignifyd in Mundelein, IL is seeking a Business Analyst focused on Life Sciences and medical device quality regulations. You will apply GxP thinking, map processes, craft user stories and support regulatory programs across FDA/regulatory frameworks.

You bring 8+ years of BA experience in life sciences or quality/regulatory roles, strong knowledge of QMS and compliance, and familiarity with eQMS/LIMS/MES and validation approaches such as GAMP 5.

Qualifications

• 8+ years as a Business Analyst in Life Sciences or Medical Device/Quality/regulatory functions.
• Strong domain knowledge of quality management systems and regulations including FDA 21 CFR Part 820, ISO 13485, 21 CFR Parts 210 & 211, 21 CFR Part 11, and EU MDR with EUDAMED.
• Experience with eQMS, PLM design control, LIMS, MES, and electronic device history record platforms.
• Experience with requirements management, process mapping, and user story writing.
• Experience supporting validation under Computer Software Assurance or GAMP 5.
• FDA-related experience such as remediation of warning letters or consent decrees is preferred.
• Understanding of AI applications in quality and compliance is a significant advantage.

Skills

GxP knowledge

FDA regulations

QMS regulations

Requirements management

Process mapping

User story writing

Validation experience

AI in QA/compliance

Tools

TrackWise

ETQ

MasterControl

Veeva Vault Quality

PTC Windchill

STARLIMS

Rimsys

Jira

Azure DevOps

eQMS

Job description

Primary Skills:

Business Analyst, GxP, FDA, Quality Management Systems Regulations, FDA 21 CFR part 820 etc,.

Required Qualifications and Experience:

• 8 or more years as a Business Analyst in Life Sciences or Medical Device, or in a quality and regulatory function.
• Strong domain knowledge of quality management systems and the regulations that shape them, including FDA 21 CFR Part 820 and the Quality Management System Regulation, ISO 13485, 21 CFR Parts 210 and 211, 21 CFR Part 11, and EU MDR with EUDAMED.
• Working knowledge of eQMS, PLM design control, LIMS, MES, and electronic device history record platforms.
• Experience with requirements management, process mapping, and user story writing.
• Experience supporting validation under Computer Software Assurance or GAMP 5.
• FDA-related experience, such as remediation of warning letters or consent decrees, is preferred.
• Understanding of AI applications in quality and compliance is a significant advantage.

Preferred Skills:

• Prior experience with medical device or pharmaceutical manufacturers.
• Exposure to quality and regulatory platforms such as TrackWise, ETQ, MasterControl, Veeva Vault Quality, PTC Windchill, STARLIMS, or Rimsys.
• Familiarity with Agile delivery and backlog tools such as Jira or Azure DevOps.
• Familiarity with Computer Software Assurance and GAMP 5 validation.
• A business analysis certification such as CBAP or an IIBA credential is an advantage.