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

Are you an experienced professional in regulatory affairs looking to take a leading role in bringing innovative medical technologies to market?

BD is looking for a Senior Regulatory Affairs Specialist to join our team in Limerick, Ireland. An exciting opportunity awaits to play a key role in new product development and product changes. You will work closely with R&D and cross-functional teams. Together, you will ensure our medical devices meet global regulatory requirements.

You’ll act as a trusted expert. You will combine your knowledge of EU MDR, MDD, CE Marking, and international regulations for medical devices. This will help guide products from development through commercialization and lifecycle management.

The role

• Lead Regulatory Affairs activities throughout the process of developing products, partnering with R&D from concept through development, CE Marking and commercialization.
• Provide regulatory leadership for sustaining engineering and product change projects, assessing regulatory impact and defining strategies.
• Develop practical approaches to intricate regulatory issues and take a hands-on approach to driving projects through to completion.
• Prepare, review and approve technical documentation, ensuring adherence to the EU medical device regulations and directives as well as BD quality systems.
• Review product and process changes, labelling, claims, complaints and advertising and promotional materials to resolve regulatory requirements.
• Provide regulatory expertise to Clinical Evaluation Reports (CERs), Periodic Safety Update Reports (PSURs), risk management activities and quality system procedures.
• Assess changes to regulations and standards, resolving their impact on products and the wider business.
• Support MDD-to-MDR transitions, product registrations and regulatory authority or notified body audits where required.

Skills and Experience Required:

• Extensive background in regulatory matters within the medical device industry, with a strong track record of managing sophisticated regulatory activities
• Experience handling medical devices classified as Class IIa and/or Class IIb under MDD and MDR regulations.
• Demonstrated ability to lead regulatory activities, influence cross-functional partners and provide solutions to sophisticated regulatory challenges.
• Proven capability to direct regulatory activities, engage cross-functional collaborators, and deliver solutions to complex regulatory challenges.
• Demonstrable experience supporting EU MDR compliance and CE Marking.
• Working knowledge of key medical device standards, including IEC/EN 60601-1, IEC/EN 60601-1-2, IEC 62304, IEC 62366, ISO 14971 and ISO 13485.
• Good knowledge of Design Control, software lifecycle, risk management and verification & validation processes.
• Capable of converting sophisticated regulatory requirements into practical solutions for cross-functional teams.
• A proactive, collaborative approach demonstrating a deep sense of ownership and the ability to thrive in a fast paced environment.

Why join BD?

This opportunity allows you to take on a highly influential Regulatory Affairs position. You’ll work directly with technical teams and collaborative groups on products throughout their lifecycle.

You’ll have the autonomy to guide regulatory activities. You will tackle complex challenges and use your expertise to help ensure innovative medical technologies reach and stay on global markets.

If you’re an experienced medical device Regulatory Affairs professional looking for your next challenge in Limerick, we’d love to hear from you.

Please note: This role is based at our Limerick site where you will be required to be on site 4 days per week.

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.

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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.

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