Staff Regulatory Specialist- Post Market Intelligence
Core
Assess adverse events and post-market information for medical devices to ensure compliance with global regulatory requirements and identify safety signals.
Role type
Staff Regulatory Specialist (Post Market Intelligence)
Builds
Regulatory submissions and safety reports for medical device manufacturers
Domain
Medical Devices / Regulatory Affairs
Deliverable
dashboards & analysis
Required skills
Adverse event assessment, regulatory reporting (MDR/AER), post-market surveillance, complaint evaluation, global regulatory compliance, risk management, trend analysis, process improvement
Preferred skills
Medical Device Reporting (MDR), vigilance reporting, ISO 13485/14971/EU MDR knowledge, root cause analysis, Power BI/Power Automate/Excel VBA
Technologies
Microsoft Excel, PowerPoint, Power BI, Power Automate
Responsibilities
Perform adverse event assessment and regulatory reporting; review product complaints to determine reportability; prepare and submit MDRs; analyze data to identify safety signals; collaborate with cross-functional teams; support audits; identify process automation opportunities.
Seniority
Staff, hands-on IC with strategic oversight
