Senior Regulatory Strategist, MedTech Global Markets

BD; Limerick; On-site; EUR 57,000 - 86,000; Full time

Job summary

BD is a global medical technology company focused on Advancing the world of health. We are seeking a Senior Regulatory Affairs Specialist to support the infusion preparation and delivery portfolio, ensuring regulatory compliance across the product lifecycle.

You will collaborate with Quality, R&D, Medical Affairs, and Marketing to integrate regulatory requirements into development and documentation, enabling timely market access and successful commercialization of healthcare solutions.

Qualifications

• Bachelor's degree in Regulatory Science, Biomedical Engineering, Pharmaceutical Sciences, Life Sciences, or related.
• Proven Regulatory Affairs experience in the medical device industry.
• Knowledge of regulatory 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.

Responsibilities

• Provide regulatory guidance for product development, design changes, and change control throughout the 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.
• 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.
• Partner withQuality, R&D, Medical Affairs, and Marketing to ensure regulatory requirements are embedded in project deliverables.
• Identify regulatory risks and compliance challenges, investigate root causes, and propose practical solutions.
• Contribute to continuous improvement initiatives strengthening regulatory processes and quality systems.

Skills

Regulatory Affairs experience

Regulatory knowledge

Regulatory submissions

Quality systems

Education

Bachelor's degree in Regulatory Science / related field

Job description

BD is a global medical technology company focused on Advancing the world of health. We are seeking a Senior Regulatory Affairs Specialist to support the infusion preparation and delivery portfolio, ensuring regulatory compliance across the product lifecycle.

You will collaborate with Quality, R&D, Medical Affairs, and Marketing to integrate regulatory requirements into development and documentation, enabling timely market access and successful commercialization of healthcare solutions.