Corza Medical · 1 week ago
Senior Regulatory Affairs Specialist – International Product Registration
United States
Full-time
Remote
Mid, Senior Level
$100K/yr - $108K/yr
5+ years expCorza Medical is dedicated to providing exceptional products and services to surgical providers. They are seeking a Senior Regulatory Affairs Specialist to lead the International Product Registration mailbox and support global market access for their medical device portfolio, ensuring compliance and enhancing global readiness.
MedicalMedical Device
Responsibilities
Own and manage the global registration mailbox with precision and responsiveness
Triage, prioritize, and respond to inquiries from distributors, affiliates, and internal teams
Maintain service-level expectations and ensure documentation accuracy in all responses
Maintain and update controlled documents including Declarations of Conformity, certificates, labeling, IFUs, and technical documentation
Ensure version control, traceability, and alignment with QMS requirements
Support document lifecycle management in partnership with Quality and Document Control
Prepare and maintain regulatory documentation packages for international submissions across LATAM, APAC, Middle East, Africa, and EU markets
Interpret and apply country-specific regulatory requirements with a Quality-driven mindset
Work closely with Quality, Supply Chain, Commercial, and Product Management to gather data and resolve registration-related questions
Serve as a reliable, detail-oriented liaison between RA and international distributors
Serve as a supervisor and mentor to junior RA staff
Develop and refine mailbox workflows, templates, and documentation standards to improve consistency and reduce rework
Identify systemic issues and partner with Quality to implement corrective and preventive actions
Support internal and external audits by providing registration evidence and documentation
Qualification
Required
Bachelor's degree in a scientific, engineering, or Quality-related discipline
5–7+ years of experience in Regulatory Affairs or Quality Assurance within the medical device industry
Strong understanding of ISO 13485, FDA QSR, EU MDR, and global regulatory frameworks
Demonstrated experience with document control, change management, or QMS processes
Ability to interpret technical documentation and communicate regulatory requirements clearly
Exceptional organizational skills and comfort managing high-volume, detail-heavy workflows
Strong written communication skills with a commitment to accuracy and compliance
Benefits
Medical
401K
Vacation and sick time
Paternal leave
Other benefits
Company
Corza Medical
Corza Medical is a provider of surgical medical devices.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Gregory Lucier
Executive Chairman & Founder
Recent News
Corza Medical Inc.
2025-11-07
Company data provided by crunchbase