Senior Regulatory Affairs Specialist – MedTech Devices

BD (Becton, Dickinson and Company); Limerick; On-site; EUR 85,000 - 95,000; Full time

Job summary

Becton, Dickinson and Company in Ireland (Limerick) is seeking a Staff Regulatory Affairs Specialist to lead regulatory submissions and drive global regulatory strategies for medical devices. You will collaborate with QA, R&D and Medical Affairs to ensure compliance across US, EU, and other regions.

The role requires 5–7 years in Regulatory Affairs within the medical device sector, with experience in 510(k) and EU MDR documentation.

Qualifications

• Bachelor's degree in Regulatory Science, Biomedical, Pharmaceutical, or related field (or equivalent).
• 5-7 years of Regulatory Affairs experience in the medical device industry (Class II/III preferred).
• Experience preparing and managing regulatory submissions (510(k), EU MDR, etc.).

Responsibilities

• Serve as Regulatory Affairs representative on cross-functional product development teams, ensuring compliance with US, EU MDR, and global requirements.
• Lead preparation, submission, and lifecycle management of regulatory filings (FDA 510(k), Pre/Q-Sub, EU technical docs for CE).
• Act as primary liaison with FDA, EU Notified Bodies and other regulatory authorities during submissions and audits.
• Develop and execute global regulatory strategies to support market access and lifecycle management.
• Review design control documentation, labeling, and promotional content for regulatory compliance.

Skills

Regulatory knowledge

Cross-functional collaboration

Regulatory submissions

Regulatory strategy

Education

Bachelor's degree in Regulatory Science/Biomedical/Pharmaceutical or related field

Tools

FDA submissions process

EU MDR documentation

Job description

Becton, Dickinson and Company in Ireland (Limerick) is seeking a Staff Regulatory Affairs Specialist to lead regulatory submissions and drive global regulatory strategies for medical devices. You will collaborate with QA, R&D and Medical Affairs to ensure compliance across US, EU, and other regions.

The role requires 5–7 years in Regulatory Affairs within the medical device sector, with experience in 510(k) and EU MDR documentation.