Nordson Corporation · 8 hours ago
Senior Specialist, Regulatory Affairs and Quality
St. Petersburg, FL
Full-time
Onsite
Senior Level
5+ years expNordson Corporation is a global leader in Interventional Solutions and is seeking an experienced Senior Regulatory & Quality Specialist to join their team. This role is responsible for ensuring adherence to FDA and ISO regulatory requirements and involves managing regulatory submissions, quality system management, and cross-functional collaboration.
IndustrialManufacturingPackaging ServicesTest and Measurement
Responsibilities
Prepare, review, and maintain regulatory submissions, including 510(k)s, technical files, design dossiers, and device registrations
Lead or support communication with regulatory bodies (FDA, notified bodies, and other authorities)
Monitor and interpret regulatory changes
Maintain regulatory documentation, labeling, and product classification information
Ensure company compliance with product‑specific reporting requirements
Maintain and improve the Quality Management System (QMS) in accordance with regulatory and internal requirements
Facilitate internal audits and support external audits from FDA, ISO registrars, and customers
Manage CAPA investigations, nonconformance reports, complaint files, and root cause analyses
Participate in design control processes, including design reviews, verification/validation documentation, and change control
Support complaint handling, adverse event reporting, and trend analysis
Coordinate corrective and preventive actions based on post‑market feedback
Maintain vigilance reporting documentation and participate in product safety evaluations
Work closely with Engineering, Manufacturing, Supply Chain, and Operations to support compliance in product development, production, and supplier management
Assist with supplier audits, qualification, and ongoing performance monitoring
Provide regulatory and quality input to new products
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related field, required
5+ years of experience in medical device regulatory or quality roles required
Hands‑on experience with FDA and ISO requirements
Experience preparing regulatory submissions such as 510(k) and supporting CE marking documentation
Strong understanding of CAPA processes, and audit practices
Excellent technical writing, documentation, and communication skills
RAC (Regulatory Affairs Certification) or ASQ CQE/CQA certifications
Experience with international regulatory pathways
Experience supporting FDA inspections or ISO audits
Company
Nordson Corporation
At Nordson, we believe that anything is possible.
5001-10000 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.45B2024-09-04Post Ipo Debt· $600M
2023-09-08Post Ipo Debt· $850M
1979-12-21IPO
Leadership Team
Sundaram Nagarajan
President and CEO
Sarah Siddiqui
EVP, CHRO Nordson Corporation
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