EMEA Regulatory & Quality Lead – Medical Devices

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

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