Senior Regulatory Affairs Specialist - MedTech Global

Becton Dickinson; Limerick; On-site; EUR 76,000 - 116,000; Full time

Benefits offered by this job

Bonus

Benefits

Job summary

BD, a global medical technology company, seeks a Staff Regulatory Affairs Specialist to lead regulatory activities for infusion devices. You will collaborate with QA, R&D, and Medical Affairs to ensure compliance with US FDA and EU MDR requirements.

The role demands independent project management and proactive regulatory risk mitigation. The candidate should have 5–7 years in regulatory affairs for medical devices, ISO 13485 experience, and strong communication skills for global teams.

Qualifications

• Bachelor’s degree in regulatory science, biomedical, pharmaceutical or related field.
• 5–7 years regulatory affairs experience in medical devices.
• Experience preparing regulatory submissions (510(k), EU MDR docs).
• Knowledge of FDA and EU MDR regulations.

Responsibilities

• Serve as regulatory affairs representative on cross-functional product development teams.
• Lead preparation, submission, and lifecycle management of regulatory filings (FDA/EU).
• Act as liaison with FDA, EU Notified Bodies and other authorities.
• Develop and execute global regulatory strategies for market access.

Skills

Collaboration

Communication

Critical Thinking

Decision Making

Analytical Thinking

Regulatory Knowledge

Regulatory Strategy

Education

Bachelor’s degree in Regulatory Science/ Biomedical/ Pharmaceutical

Tools

Microsoft Office

Job description

BD, a global medical technology company, seeks a Staff Regulatory Affairs Specialist to lead regulatory activities for infusion devices. You will collaborate with QA, R&D, and Medical Affairs to ensure compliance with US FDA and EU MDR requirements.

The role demands independent project management and proactive regulatory risk mitigation. The candidate should have 5–7 years in regulatory affairs for medical devices, ISO 13485 experience, and strong communication skills for global teams.