Job Description Summary

The Senior Regulatory Affairs Specialist will ensure that BD fulfils the responsibilities and activities of BD as European Authorised Representative (EAR), as Swiss Authorised Representative (CH-Rep) and UK Responsible Person (UK-RP). The role will also support the wider EMEA regulatory affairs team as required. The Senior Regulatory Affairs Specialist will lead regulatory activities or projects, train junior team members, and act as a key liaison with regulatory bodies and internal stakeholders.

Job Description

We are the makers of possible

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.

Why join us?

A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

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 health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

Become a maker of possible with us!

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

The Senior Regulatory Affairs Specialist at BD is responsible for ensuring the company meets its obligations as the European Authorised Representative (EAR), Swiss Authorised Representative (CH-Rep), and UK Responsible Person (UK-RP). This includes obtaining and maintaining mandates with manufacturers, reviewing technical documentation, creating and submitting registration packages, and ensuring compliance with relevant regulatory requirements. The role also involves performing impact assessments, leading derogations, supporting audits, obtaining free sale certificates, and maintaining regulatory databases to track key data such as approvals, non-conformities, and submission timelines.

In addition to these responsibilities, the Senior Regulatory Affairs Specialist will act as a subject matter authority, providing training and guidance to junior team members, staying informed on regulatory changes, and ensuring the team is updated with new requirements. The role also involves preparing and reviewing corrective and preventive actions (CAPA) and leading Quality Management System (QMS) documents for various entities. As part of the wider EMEA regulatory affairs team, the Specialist will collaborate with internal and external partners to address customer and regulatory agency queries and ensure smooth compliance with all regulatory obligations.

Main responsibilities will include:

• Ensure the responsibilities of BD as EAR, CH-Rep and UK-RP (collectively referred to as AR within this job description) are met, including but not limited to:

• Obtaining and maintaining AR mandates with each of the applicable manufacturers.

• Obtaining and reviewing technical documentation to ensure it meets the AR obligations.

• Creating, submitting and maintaining dossiers and submission packages to meet the registration obligations of the AR.

• Review and approve first-article inspection forms.

• Perform impact assessments.

• Prepare, review and submit derogations.

• Provide support to AR audits.

• Obtain free sale certificates to support the global market, including meeting any associated consular services and invoicing needs.

• Liaise with internal and/or external customers as appropriate to promptly resolve customer, Notified Body and regulatory agency queries.

• Maintain regulatory databases/systems for key regulatory data (e.g. regulatory body communications, approvals, non-conformities, submission timelines).

• Provide and maintain metrics as required.

• Understand and communicate AR regulatory requirements to other teams/departments.

• Follow the department and company procedures.

• Creation and maintenance of procedures as required.

• Act as an effective subject matter expert for an area.

• Stay updated with regulatory changes and ensure the team is informed of new requirements.

• Train and provide guidance to junior regulatory affairs specialists.

• Prepare and review CAPA actions.

• Prepare and maintain QMS documents for the different entities acting as Authorised Representative.

• May perform other duties as required in support of the RA EMEA department.

About you

• Excellent Communication Skills

• Can Do Attitude

• Strategic Way of thinking and Hands On.

• 5+ Years of Experience working in a Highly Regulated Environment (Medical Devices or Pharma).

Click on apply if this sounds like you!

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.

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

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Primary Work Location

IRL Drogheda - Donore Rd

Additional Locations

Work Shift