Senior Specialist, Regulatory Affairs and Quality
Halkey-Roberts Corporation

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.

Job Summary

The Senior Regulatory & Quality Specialist will support and strengthen our compliance activities within an FDA-regulated and ISO-certified medical device environment. This role is responsible for ensuring adherence to FDA, ISO and related global regulatory requirements.

The ideal candidate brings strong experience with regulatory submissions, quality system management, document control, and post-market compliance, along with excellent communication skills and the ability to collaborate cross-functionally.

Essential Job Duties and Responsibilities

Regulatory Affairs

• 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.

Quality System Management

• 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.

Post-Market Surveillance

• 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.

Cross-Functional Collaboration

• 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

Education and Experience Requirements

• 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.

Interested?

If you are interested in being a part of a team and creating an inclusive and diverse workplace, please apply online with your CV.

About Nordson Medical

At Nordson MEDICAL, you don't have to be a doctor to help save lives. We are the global expert in the design, development, and manufacturing of complex medical devices and component technologies. By joining our team today, you will help us bring innovative ideas to life. Nordson MEDICAL is a global team that works to create components for life-saving medical devices. We offer a supportive culture in a growing and dynamic work environment. Whether you're just beginning your career or you're a seasoned professional, there's a place for you to belong at Nordson MEDICAL. We offer hourly and salary positions in production, maintenance, customer service, quality, engineering, and more. We actively invest in our teams to help you build your skillsets and advance your career.

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