Senior Regulatory Affairs Specialist

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

Benefits offered by this job

Total Rewards program

Competitive compensation

Job summary

BD (Becton, Dickinson and Company) in Limerick, Ireland, is seeking a Senior Regulatory Affairs Specialist to support the infusion preparation and delivery portfolio, ensuring regulatory compliance across the product lifecycle. You will work with Quality, R&D, Medical Affairs and Marketing to enable timely market access for innovative healthcare solutions.

You will interpret EU MDR, UK MDR and FDA requirements, prepare technical documentation, and contribute to continuous improvement of

Qualifications

• Regulatory 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.

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 for 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 Quality, R&D, Medical Affairs, and Marketing to ensure regulatory requirements are incorporated into deliverables.
• Identify regulatory risks and compliance challenges, investigate root causes, and propose practical solutions.
• Contribute to continuous improvement of regulatory processes and quality systems.

Skills

Regulatory affairs

Medical devices

Regulatory submissions

EU MDR knowledge

Analytical skills

Education

Bachelor's degree in Regulatory Science or related field

Job description

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. 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.

BD is proud to be certified as a Top Employer 2026 in Europe, reflecting our commitment to creating an exceptional working environment. 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.

Required Skills Optional Skills . Primary Work Location IRL Limerick - Castletroy Additional Locations Work Shift 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 BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.