Nordson Corporation · 22 hours ago
Senior Manager, Regulatory and Quality Affairs
St. Petersburg, FL
Full-time
Onsite
Senior Level
7+ years expNordson Medical is a global leader in Interventional Solutions and is seeking a Senior Manager for Regulatory and Quality Affairs. This role is responsible for leading the development and implementation of the Quality Management System, ensuring compliance with FDA and ISO regulations, and driving a culture of quality and operational excellence across the organization.
IndustrialManufacturingPackaging ServicesTest and Measurement
Responsibilities
Provide strategic leadership and oversight for all Quality functions, including Quality Assurance, Quality Control, Document Control, Supplier Quality, and Regulatory Compliance
Ensure company-wide compliance with FDA, ISO 13485, and EU MDR/CE regulations, as well as other applicable global standards
Oversee the development, validation, and maintenance of systems supporting design controls, CAPA, risk management, complaints handling, and product release
Partner with R&D, Operations, and Regulatory teams to ensure quality considerations are integrated throughout the design, verification, validation, and clinical trial processes
Lead and mentor a team of quality professionals, fostering a proactive, solutions-oriented, problem-solving, and compliance-driven culture
Drive continuous improvement initiatives aligned with NBS Next principles to enhance quality performance and reduce cost of poor quality (COPQ)
Support post-market surveillance and risk management activities, including adverse event investigations and product recall processes when applicable
Collaborate with manufacturing and supply chain teams to ensure supplier quality systems and processes meet global regulatory and customer expectations
Serve as a key quality liaison with clinical and regulatory authorities as needed to support product submissions, inspections, and approvals
Be an engaging, visible leader who is actively involved in the business, making key decisions that support the long-term growth, compliance, and success of the organization
Qualification
Required
Bachelors degree in a technical field required
7-10 years experience in the medical device industry
Extensive experience designing robust quality management systems that withstand regulatory inspections
Experience with quality systems regulations and standards including 21 CFR 820, ISO 13485:2003 CE Marking, FDA GMP and internal auditing
Experience with 510(k) Premarket Notification
Experience in preparing technical files and design dossier
Experience with EU Medical Device Directive (MDD) and Canadian Medical Devices Regulation (CMDR) and Design Controls
Experience with other regulatory bodies in rest of world is a plus, particularly in Japan and China
Preferred
Biomedical or mechanical engineering preferred
Masters degree a plus
RAC and ASQ certifications are a plus
Extensive experience with biomaterials and medical device R&D is preferred
Experience with Investigational Device Exemption (IDE) and Premarket Approval (PMA) is a plus
Wide breadth and depth of regulatory, clinical and quality knowledge, experience, and expertise with a variety of medical devices
A thorough understanding of US and OUS regulatory, CE, and quality assurance requirements
Experience with FDA QSR, ISO 13485:2003 and the principles of the EU Medical Device Directive (93/42/EEC) requirements
Company
Nordson Corporation
At Nordson, we believe that anything is possible.
5001-10000 employees
H1B Sponsorship
Nordson Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
2023 (5)
2021 (4)
2020 (1)
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
Recent News
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