Business Analyst

We are looking for an experienced Business Analyst / QA Compliance Specialist with a strong background in FDA-regulated environments, particularly within the Medical Device, Pharmaceutical, Healthcare, or Life Sciences industries.

The ideal candidate will have experience supporting business requirements, quality assurance, software validation, and regulatory compliance initiatives. Candidates with either Business Analysis, QA, Quality Systems, or Validation experience are encouraged to apply, provided they have hands-on experience working in an FDA-regulated environment.

• 8+ years of experience in Business Analysis, QA, Quality Systems, Software Validation, or a related discipline.
• Strong hands-on experience in an FDA-regulated industry is mandatory.
• Working knowledge of FDA 21 CFR Part 820, 21 CFR Part 11, CAPA, and ISO 13485.
• Experience with requirements documentation, testing, validation, or quality compliance processes.
• Familiarity with Computer Software Assurance (CSA), GAMP 5, or software validation methodologies.
• Experience supporting audits, regulatory documentation, and compliance activities.
• Excellent analytical, documentation, communication, and stakeholder management skills.
• Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related field is typically preferred.

Preferred Qualifications:

• Experience with eQMS platforms such as TrackWise, Master Control, or Veeva Vault Quality.
• Knowledge of FDA Quality Management System Regulation (QMSR) requirements.
• Experience in medical device, pharmaceutical, biotechnology, or life sciences environments.
• Exposure to Agile methodologies and cross-functional project teams.
• Collaborate with business, quality, regulatory, and technical teams to gather, analyze, and document business and compliance requirements.
• Support quality assurance activities, software testing, UAT, and validation initiatives.
• Assist with Quality Management Systems (QMS), CAPA, deviation management, and change control processes.
• Ensure compliance with applicable FDA regulations, quality standards, and industry guidelines.
• Develop and maintain regulatory documentation, SOPs, test plans, validation protocols, and compliance records.
• Support audit preparation, regulatory inspections, compliance assessments, and remediation efforts.
• Participate in process improvement initiatives to enhance quality, compliance, and operational efficiency.
• Work closely with cross-functional teams to ensure quality and regulatory requirements are incorporated into business and technical solutions.