Senior Regulatory Affairs Strategist – MedTech Compliance

BD (Becton, Dickinson and Company); Limerick; On-site; EUR 57,000 - 86,000; Full time

Job summary

BD (Becton, Dickinson and Company) is seeking a Senior Regulatory Affairs Specialist to support infusion preparation and delivery products. You will provide regulatory expertise across the product lifecycle, ensuring compliance for global markets and enabling timely market access and commercialization.

You will collaborate with Quality, R&D, Medical Affairs, and Marketing to integrate regulatory requirements into development and documentation, contributing to successful healthcare solutions.

Qualifications

• 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 EU MDR, UK MDR, FDA requirements, and other international frameworks.
• Experience with ISO 13485 quality management systems.

Responsibilities

• Provide regulatory guidance for product development and changes across the lifecycle.
• Review and approve regulatory submissions and technical documentation.
• Support global market access and product launches.
• Prepare and maintain registrations and registrations for global markets.
• Communicate regulatory requirements to cross-functional teams.
• Identify regulatory risks and propose practical solutions.
• Contribute to continuous improvement of regulatory processes.

Skills

Regulatory affairs

Medical devices

Regulatory submissions

EU MDR

Regulatory compliance

Education

Bachelor's degree in Regulatory Science, Biomedical Engineering, Pharmaceutical Sciences, Life Sciences, or a related discipline

Job description

BD (Becton, Dickinson and Company) is seeking a Senior Regulatory Affairs Specialist to support infusion preparation and delivery products. You will provide regulatory expertise across the product lifecycle, ensuring compliance for global markets and enabling timely market access and commercialization.

You will collaborate with Quality, R&D, Medical Affairs, and Marketing to integrate regulatory requirements into development and documentation, contributing to successful healthcare solutions.