Senior Regulatory & Quality Lead – EMEA

Becton, Dickinson and Company; The Borough District of Drogheda; On-site; EUR 57,000 - 86,000; Full time

Job summary

BD is seeking a Senior Quality and Regulatory Affairs Specialist to join the EO Hub, ensuring compliance with EU, UK, and Swiss regulations for Authorised Representatives, Importers, and Distributors. You will lead regulatory impact assessments, implement compliance plans, and support device registrations and regulatory submissions across the EMEA region.

The role requires strong knowledge of MDR/IVDR and related regulatory requirements, with involvement in audits, CAPA, and continuous

Qualifications

• Strong knowledge of EU MDR (2017/745), IVDR (2017/746), UK Medical Device Regulations, and Swiss regulatory requirements.
• Experience conducting regulatory impact assessments, gap analyses, and compliance evaluations.
• Hands-on experience supporting device registrations, technical documentation reviews, authorised representative activities, and regulatory submissions.

Responsibilities

• Monitor EU/UK/Swiss regulatory developments and communicate requirements to stakeholders.
• Conduct regulatory impact assessments and gap analyses to evaluate compliance.
• Develop and execute compliance implementation plans across the business.
• Provide regulatory guidance to cross-functional teams on EO requirements (Authorised Representatives, Importers, Distributors).
• Support device registrations, technical documentation reviews, and regulatory submissions.
• Maintain quality system documentation and records related to compliance.
• Support audits, inspections, and regulatory assessments with documentation and responses.
• Analyse compliance metrics and deliver training to promote regulatory culture.

Job description

BD is seeking a Senior Quality and Regulatory Affairs Specialist to join the EO Hub, ensuring compliance with EU, UK, and Swiss regulations for Authorised Representatives, Importers, and Distributors. You will lead regulatory impact assessments, implement compliance plans, and support device registrations and regulatory submissions across the EMEA region.

The role requires strong knowledge of MDR/IVDR and related regulatory requirements, with involvement in audits, CAPA, and continuous