MDR & Post-Market Medical Device Vigilance Associate

Sigmar Recruitment; Galway; Hybrid; EUR 42,000 - 60,000; Full time

Job summary

Sigmar Recruitment is seeking an Associate MDR Vigilance Specialist to join a leading medical device environment in Galway on a 12-month contract with hybrid working arrangements. The role focuses on handling product complaints, MDR preparation, and regulatory reporting, ensuring patient safety and compliance.

Ideal candidates hold a NFQ Level 8 degree in science/engineering or a clinical field, with 1–2 years of regulated industry experience and strong attention to detail.

Qualifications

• Bachelor’s degree at NFQ Level 8 or equivalent in Science, Engineering, Law, a clinical discipline or related field.
• Prior experience in a medical device, pharmaceutical or regulated environment is desirable.
• Approximately 1–2 years of relevant experience is advantageous, though candidates with limited experience will be considered.
• Basic understanding of anatomy, physiology and medical terminology.

Responsibilities

• Receive, document and coordinate product complaints with high-quality records.
• Coordinate investigations with cross-functional teams and support root cause analysis.
• Assist post-market surveillance, including processing adverse event reports.
• Prepare and maintain Medical Device Reports (MDRs) and safety documentation per regulatory requirements.
• Support responses to regulatory agency queries relating to complaints and safety reports.

Skills

Attention to detail

Analytical thinking

English fluency

Cross-functional collaboration

Documentation skills

Education

Bachelor’s degree or NFQ Level 8 in Science/Engineering/Clinical field

Job description

Sigmar Recruitment is seeking an Associate MDR Vigilance Specialist to join a leading medical device environment in Galway on a 12-month contract with hybrid working arrangements. The role focuses on handling product complaints, MDR preparation, and regulatory reporting, ensuring patient safety and compliance.

Ideal candidates hold a NFQ Level 8 degree in science/engineering or a clinical field, with 1–2 years of regulated industry experience and strong attention to detail.