Quality & Regulatory Engineer

Role and Responsibilities:

5+ years of experience in Quality Assurance, Regulatory Affairs, or Quality Systems within Medical Device industry.Execute updates to quality records and ensure documentation accuracy, completeness, and compliance. Perform documentation consistency reviews across QMS, technical, and regulatory documents. Manage controlled document creation, revision, approval, and implementation activities. Conduct compliance reviews against applicable regulations, standards, and internal procedures. Prepare, organize, and maintain audit evidence for internal, customer, certification, and regulatory audits. Coordinate and resolve review comments from cross-functional stakeholders, auditors, and regulatory reviewers. Compile, review, and finalize Project closure packages, ensuring required documentation is complete and audit ready. Support CAPA, change control, risk management, and document control processes as required. Collaborate with Quality, Regulatory, R&D, Manufacturing, and Supply Chain teams to ensure compliance and timely project execution.

Skills:

Expertise in Quality Management Systems (QMS), including Document Control, Change Management, CAPA, Nonconformance Management, and Quality Records Management. In-depth knowledge of medical device regulations and standards, including ISO 13485, FDA 21 CFR Part 820/QMSR, ISO 14971, and applicable global regulatory requirements. Proven capability in conducting Documentation Consistency Reviews, Compliance Assessments, and ensuring alignment across quality, regulatory, design, and manufacturing records. Strong understanding of Risk Management, CAPA processes, and Design Control documentation, ensuring traceability and regulatory compliance. Expertise in Audit Preparation, Inspection Readiness, Audit Evidence Compilation, and supporting internal, customer, certification, and regulatory audits. Experience managing Documentation Closure Packages, remediation projects, product transfer activities, and regulatory compliance initiatives, ensuring deliverables are complete, traceable, and audit-ready. Excellent technical writing, document review, and documentation management skills with exceptional attention to detail.

Roles and Responsibilities
Execute quality-record updates, documentation consistency reviews, controlled-document updates, compliance reviews, audit-evidence preparation, review-comment resolution, and Project Alpha closure packages.