About the Role
As a Senior Regulatory Affairs Specialist, you will play an important role in supporting BD's infusion preparation and delivery portfolio, including disposable infusion sets and accessories used for the administration of fluids and medications. You will provide regulatory expertise across the product lifecycle, helping to ensure products meet regulatory requirements and remain accessible in global markets.
This position offers the opportunity to contribute to new product development, product changes, sustaining engineering initiatives, compliance activities, and market access projects. Working closely with colleagues across Quality, Research & Development, Medical Affairs, and Marketing, you will help integrate regulatory requirements into product development and documentation, supporting the successful commercialization of innovative healthcare solutions.
Responsibilities
•Provide regulatory guidance for product development, design changes, and change control activities throughout the product lifecycle.
•Review and approve technical and project documentation, including design verification reports, labeling, and regulatory submissions.
•Support product launches by developing regulatory strategies that enable timely market access and commercialization.
•Prepare, maintain, and update technical documentation, product registrations, and regulatory submissions for global markets.
•Interpret and communicate regulatory requirements, standards, and guidance documents, including EU MDR, FDA requirements, and ISO standards.
•Partner with colleagues across Quality, Research & Development, Medical Affairs, and Marketing to ensure regulatory requirements are incorporated into project deliverables.
•Identify regulatory risks and compliance challenges, investigate root causes, and recommend practical solutions.
•Contribute to continuous improvement initiatives that strengthen regulatory processes, quality systems, and business effectiveness.
Preferred Requirements
•Bachelor's degree in Regulatory Science, Biomedical Engineering, Pharmaceutical Sciences, Life Sciences, or a related discipline.
•Proven Regulatory Affairs experience within the medical device industry.
•Knowledge of medical device regulatory requirements, submissions, product registrations, technical documentation, and compliance activities.
•Understanding of EU MDR, UK MDR, FDA requirements, and other international regulatory frameworks.
•Experience working within an ISO 13485 quality management system or another regulated environment.
•Strong analytical, organizational, and communication skills, with the ability to manage multiple priorities while maintaining attention to detail.
Primary Work Location
IRL Limerick - Castletroy
Salary Range Information
€56,600.00 - €86,300.00 EUR Annual
