The Principal RA Specialist will convert legacy IVDR technical documentation into a new QMS structure while supporting global regulatory execution across the US, EU, Canada, LATAM, and APAC. This individual will act as the regulatory lead for a defined product line and partner closely with R&D, Marketing, and Quality

Responsibilities

• Lead conversion of legacy IVDR technical files into internal QMS templates
• Own regulatory strategy for a global IVD product portfolio
• Support future 510(k) and De Novo submissions
• Manage international change notifications and global registration updates
• Collaborate with cross-functional teams on software and design updates
• Support regulatory readiness for upcoming international launches beginning in 2027
• Develop regulatory documentation aligned with evolving global requirements
• Serve as regulatory representative on product core teams

Requirements

• 10+ years Regulatory Affairs experience in medical devices or IVD
• Strong authorship of IVDR technical files
• Experience supporting global submissions (US, EU, Canada, LATAM, APAC) including 510(k) authorship 
• Background in IVD regulatory pathways required
• Exposure to Software-in-Medical-Device (SiMD) and cybersecurity expectations
• Experience independently leading regulatory documentation and submissions
• Ability to operate with product-level ownership across lifecycle activities

Work Environment

• Hybrid schedule (3 days onsite weekly)

Compensation

• Base salary range: $150,000 – $170,000 + bonus