Specialist - Regulatory Affairs - Operations 4A
Core
Reviewing and managing medical device complaint records to ensure audit readiness and regulatory compliance.
Role type
Specialist, Regulatory Affairs Operations
Builds
Audit-ready complaint files and regulatory reports
Domain
Pharmaceutical/Medical Device Industry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Complaint assessment, Documentation management, Regulatory reporting (MDR/Medwatch), SOP compliance, Data gathering, Stakeholder coordination, Metrics reporting
Preferred skills
Advanced degree in Regulatory Affairs/Public Health, Certified Regulatory Compliance Manager (CRCM)
Technologies
ETQ, Complaint database software, Reporting tools
Responsibilities
Review complaint records for completeness and accuracy, Complete missing documentation and investigations, Submit Medwatch forms to health authorities, Determine reportability for US/EMEA/APAC regions, Coordinate with Quality and Regulatory Affairs teams, Maintain audit-ready documentation
Seniority
Specialist, hands-on IC