Senior Regulatory Affairs Specialist

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

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

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.ed.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Primary Work Location

IRL Limerick - Castletroy

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

€56,600.00 - €86,300.00 EUR Annual