Senior Quality and Regulatory Affairs Specialist

BD (Becton, Dickinson and Company); Drogheda; On-site; EUR 57,000 - 86,000; Full time

Job summary

BD (Becton, Dickinson and Company) is seeking a Senior Quality and Regulatory Affairs Specialist to join the QRA EMEA team, supporting the Economic Operator (EO) Hub across EU, UK and Switzerland. You will monitor regulatory developments, conduct impact assessments and drive compliance initiatives for Authorized Representatives, Importers and Distributors.

The role combines regulatory expertise, cross-functional collaboration and ongoing quality system enhancement to help maintain market access

Qualifications

• Strong knowledge of EU MDR (2017/745) and IVDR (2017/746).
• Experience with UK Medical Device Regulations.
• Experience conducting regulatory impact assessments and gap analyses.
• Proficiency in developing and maintaining regulatory documentation and submissions.
• Familiarity with Quality Management System processes and CAPA.

Responsibilities

• Monitor EU, UK, and CH regulatory developments and inform stakeholders.
• Perform regulatory impact assessments and gap analyses.
• Develop and execute compliance implementation plans.
• Provide guidance on EO requirements for registered devices.
• Support device registrations and technical documentation reviews.
• Maintain and improve QMS documentation and records.
• Assist regulatory inspections and audits and respond to inquiries.
• Analyse compliance metrics and drive continuous improvement.

Skills

EU MDR knowledge

IVDR knowledge

UK Medical Device Regulations

Regulatory submissions

QMS proficiency

Regulatory databases

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

The Senior Quality and Regulatory Affairs Specialist is responsible for providing regulatory expertise and support to the Economic Operator (EO) Hub to ensure compliance with applicable EU, UK, and Swiss regulations governing Authorised Representatives, Importers, and Distributors. This role will monitor emerging and changing regulatory requirements, assess business impact, contribute to implementation strategies, and drive compliance activities within the EO Hub department. The individual will serve as a subject matter expert, partnering with cross-functional stakeholders to communicate regulatory requirements and ensure timely implementation of regulatory obligations.

Our vision for Regulatory Affairs at BD

The Regulatory Affairs team is helping to ensure speed to market for BD's innovative medical technologies by having an acutely patient-centric mindset.

About the Role

We are seeking a highly motivated Senior Quality and Regulatory Affairs Specialist to join our Quality, Regulatory Affairs (QRA) EMEA team. In this role, you will serve as a key regulatory expert supporting the Economic Operator (EO) Hub and ensuring compliance with evolving regulatory requirements across the European Union, United Kingdom, and Switzerland. You will play a critical role in monitoring regulatory developments, conducting impact assessments, and driving the implementation of compliance initiatives related to Authorised Representatives, Importers, and Distributors. As a trusted subject matter expert, you will partner with cross-functional stakeholders to support regulatory operations, device registrations, technical documentation reviews, and economic operator activities. You will also contribute to the continuous improvement of quality system processes, support regulatory inspections and audits, manage interactions with Competent Authorities, and analyse compliance metrics to identify risks and improvement opportunities. This position offers the opportunity to influence regulatory strategy, strengthen compliance frameworks, and help ensure continued market access for medical devices across the EMEA region.

Main Responsabilities

• Monitor regulatory developments across the EU, UK, and Switzerland, assessing their impact on Economic Operator activities and communicating requirements to relevant stakeholders.


• Conduct regulatory impact assessments and gap analyses to evaluate compliance with new or updated regulations, guidance documents, and authority expectations.


• Develop and execute compliance implementation plans, ensuring timely adoption of regulatory changes across the business.


• Act as the regulatory subject matter expert for Economic Operator requirements, providing guidance and support to cross-functional teams and business partners.


• Support key regulatory operations, including Authorised Representative activities, technical documentation reviews, and device registration processes.


• Develop, maintain, and enhance quality system documentation, including procedures, work instructions, and compliance-related records.


• Support Quality Management System activities including management of non-conformities, CAPA, quality plans and other quality and compliance activities.


• Support internal and external audits, inspections, and regulatory assessments, providing regulatory expertise, documentation, and responses to compliance inquiries.


• Analyse compliance metrics, manage regulatory databases, identify potential compliance risks, and deliver training and awareness programmes to promote a strong regulatory compliance culture.

About you

• Strong knowledge of EU MDR (2017/745), IVDR (2017/746), UK Medical Device Regulations, and Swiss regulatory requirements, including Economic Operator obligations for Authorised Representatives, Importers, and Distributors.


• Experience conducting regulatory impact assessments, gap analyses, and compliance evaluations, with the ability to translate regulatory changes into actionable implementation plans.


• Hands-on experience supporting device registrations, technical documentation reviews, authorised representative activities, and regulatory submissions within the medical device industry.


• Proficiency in quality management systems (QMS), including the development and maintenance of procedures, work instructions, CAPAs, audit support activities, and regulatory compliance documentation.


• Strong analytical and project management skills, with experience using regulatory databases and compliance tracking systems to manage regulatory commitments, metrics, risk assessments, and continuous improvement initiatives.

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.

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.

Salary Range 60K - 70K + Benefits

Primary Work Location

IRL Drogheda - Donore Rd

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"

Salary Range Information

56,600.00 - 86,300.00 EUR Annual

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.