Senior Manager, Regulatory and Quality Affairs

Nordson Corporation•Saint Petersburg, FL

About The Position

Nordson Medical, a global leader in Interventional Solutions, Fluid Components, and Surgical Solutions, is seeking an experienced and highly motivated individual to join our team. We are committed to creating a diverse and inclusive workplace, and we are looking for candidates who share that same commitment. Summary of the role As a member of our team, you will have the opportunity to work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected. The Senior Manager, Regulatory and Quality is responsible for leading the development, implementation, and continuous improvement of the Quality Management System (QMS) across all manufacturing and product development operations. This role ensures compliance with FDA (21 CFR Part 820), ISO 13485, and EU MDR/CE requirements, while driving a culture of quality, operational excellence, and cross-functional collaboration. The ideal candidate is a strategic quality leader with a strong understanding of regulatory frameworks, clinical trial processes, and risk-based quality systems—capable of partnering across functions to ensure products meet global standards for safety, efficacy, and compliance.

Requirements

Strong communication skills, level-headed, good judgment, effective leadership skills, team player, personable, strong attention to detail with ability to see big picture.
The successful candidate will have a proven ability to multi-task and work collaboratively as well as independently in a dynamic and entrepreneurial environment.
Bachelors degree in a technical field required, biomedical or mechanical engineering preferred, masters degree a plus, RAC and ASQ certifications are a plus.
7-10 years experience in the medical device industry
Extensive experience with biomaterials and medical device R&D is preferred
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 with Investigational Device Exemption (IDE) and Premarket Approval (PMA) is a plus
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.

Nice To Haves

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.

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.