Staff Regulatory Affairs Specialist

BD; Limerick; On-site; EUR 76,000 - 116,000; Full time

Job summary

BD, a global medical technology leader, seeks a Staff Regulatory Affairs Specialist for the Limerick site to drive regulatory strategy for the Medication Delivery Solutions unit. You will work across QA, R&D and Medical Affairs to ensure compliance on new and existing products, guiding submissions and lifecycle management.

You will lead regulatory filings, interact with FDA and EU notified bodies, and translate requirements into actionable project plans, with a proactive risk-based approach to

Qualifications

• Bachelor’s degree in Regulatory Science, Biomedical, Pharmaceutical, or related field.
• 5–7 years of Regulatory Affairs experience in medical devices.
• Experience preparing and managing regulatory submissions (e.g., 510(k), EU MDR technical documentation).
• Strong knowledge of U.S. FDA regulations, EU MDR, and global regulatory frameworks.
• Experience with ISO 13485 and design control environments.
• Ability to manage multiple projects in a dynamic, matrixed organization.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Serve as RA representative on cross-functional product development teams to ensure regulatory compliance.
• Lead preparation, submission, and lifecycle management of regulatory filings (FDA 510(k), EU technical docs).
• Interact with FDA, EU Notified Bodies, and other authorities during submissions and audits.
• Advise on regulatory risks and mitigation strategies across projects.
• Develop and execute global regulatory strategies for market access and lifecycle management.
• Review design control documentation, labeling, and promotional materials for regulatory compliance.

Skills

Regulatory affairs

FDA regulations

EU MDR

ISO 13485

Cross-functional collaboration

Regulatory submissions

Analytical decision making

Education

Bachelor’s degree in Regulatory Science/Biomedical/Pharmaceutical

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

Our vision for Medication Delivery Solutions at BD

As a leading manufacturer and supplier of products that are used daily in healthcare, the Medication Delivery Solutions (MDS) team provide a wide range of products for injection and infusion therapy, regional anaesthesia and closed medication management.

About The Role

The Staff RA Specialist will represent Regulatory Affairs within the Worldwide Infusion Preparation and Delivery (WWIPD) platform, part of the Medication Delivery Solutions business unit of Becton Dickinson (BD). This is a highly visible role within the organisation that will participate in multi-functional teams as the regulatory expert on compliance projects, product engineering, new product development, and other regulatory-related development initiatives and maintenance activities. The role will work closely with the other functions (QA, R&D, Medical Affairs, etc.) to ensure that all regulatory requirements are identified and effectively addressed within projects.

Main Responsibilities Will Include

• Serve as the Regulatory Affairs representative on cross-functional product development teams, ensuring compliance with U.S., EU MDR, and global regulatory requirements for new products and design changes
• Lead preparation, submission, and lifecycle management of regulatory filings, including FDA 510(k), Pre/Q-Sub, and EU technical documentation for CE marking
• Act as primary liaison with FDA, EU Notified Bodies, and other regulatory authorities during submissions, audits, and ongoing compliance activities
• Serve as a point of contact for EU notified bodies and other regulatory agencies during submissions and surveillance audits.
• Independently assess product and process changes for regulatory impact and determine appropriate submission or non-submission pathways
• Develop and execute global regulatory strategies to support timely market access and lifecycle management of medical devices
• Review and approve design control documentation, labelling, promotional materials, and other regulated content to ensure compliance with applicable requirements
• Identify, evaluate, and communicate regulatory risks, and recommend mitigation strategies to cross-functional stakeholders
• Maintain current knowledge of evolving global regulations and proactively advise project teams on potential impacts
• Collaborate with global regulatory partners to support international registrations and market expansion
• Drive continuous improvement by identifying process inefficiencies and implementing enhancements to regulatory workflows
• Executes the above tasks with limited supervision.

About You

• Bachelor’s degree in Regulatory Science, Biomedical, Pharmaceutical, or related scientific field (or equivalent)
• 5–7 years of Regulatory Affairs experience in the medical device industry, preferably with Class II and/or Class III devices
• Demonstrated experience preparing and managing regulatory submissions (e.g., 510(k), EU MDR technical documentation)
• Strong working knowledge of U.S. FDA regulations, EU MDR (Regulation (EU) 2017/745), and applicable global regulatory frameworks
• Experience operating within an ISO 13485 quality system and design control environment
• Proven ability to manage multiple projects independently in a dynamic, matrixed organisation
• Strong analytical, critical thinking, and decision-making skills, with the ability to translate regulatory requirements into actionable strategies
• Effective communication and collaboration skills, with experience working across cross-functional and global teams

Additional Qualifications

• Demonstrated ability to mentor or guide colleagues and influence stakeholders
• Strong attention to detail with a proactive, solution-oriented mindset
• Experience in regulatory strategy development and risk-based decision-making
• Continuous improvement mindset with ability to identify and implement process enhancements
• Proficiency with standard business tools (e.g., Microsoft Office suite)
• Ability to operate effectively in a global, multicultural environment and travel as needed

Primary Work Location

IRL Limerick - Castletroy

Salary Range Information

€75,900.00 - €115,725.00 EUR Annual

Salary €85K - €95K + Bonus + Benefits

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.