Not specified (likely hybrid or onsite based on industry norms).
510(k) management
Fda submissions
Iso 13485
2San, a global diagnostics company, is seeking a Global Regulatory Specialist to manage regulatory compliance for in vitro diagnostic devices. The ideal candidate should have experience in regulatory affairs, particularly with Class 2 and Class 3 IVDs, and demonstrate strong analytical and communication skills
Job Summary
2San is a global diagnostics company transforming healthcare with innovative home-testing solutions.
The Global Regulatory Specialist will monitor and manage regulatory entries for Class 2 and Class 3 Self-Test IVDs.
This role involves collaborating with product development, managing QMS, and ensuring compliance with US and international standards.
Matching Summary
Match Score: 85
2San, a global diagnostics company, is seeking a Global Regulatory Specialist to manage regulatory compliance for in vitro diagnostic devices. The ideal candidate should have experience in regulatory affairs, particularly with Class 2 and Class 3 IVDs, and demonstrate strong analytical and communication skills.
Salary
$60,000 USD per year
Skills & Requirements
Must-have
510(k) management
FDA submissions
ISO 13485
Quality Management System
Post-Market Surveillance
Nice-to-have
Agile work ethic
High-impact communication
Relentless focus on milestones
Positive can-do attitude
Collaborative relations
Key Requirements
3+ years direct regulatory experience in IVD or Medical Device