Associate MDR Vigilance Specialist

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

Associate MDRVigilance Specialist

Location: Galway
Job Type: Contract
Duration: 12 months, with potential for extension
Hybrid
About the Role

We are seeking an Associate MDRVigilance Specialist to join a leading medical device environment in Galway. This is an excellent opportunity for a science, engineering or clinical graduate to develop their expertise in medical device vigilance, complaint handling and post-market surveillance.

Working alongside experienced professionals and cross-functional teams, you will support the investigation of product complaints, regulatory reporting and safety monitoring activities, helping to ensure compliance with applicable regulatory requirements and maintain a strong focus on patient safety.

Key Responsibilities

• Receive, document and coordinate product complaints, ensuring records are accurate, complete and maintained to a high standard.

• Coordinate complaint investigations with cross-functional teams and support root cause analysis.

• Assist with post-market surveillance activities, including the assessment, processing and follow-up of adverse event reports.

• Prepare and maintain Medical Device Reports (MDRs) and other relevant safety documentation in line with regulatory requirements.

• Support responses to regulatory agency queries relating to product complaints and safety reports.

• Review and analyse complaint data to support accurate reporting and the preparation of safety summaries.

• Contribute to risk assessments, risk analysis and health hazard evaluations associated with product complaints.

• Liaise with internal stakeholders and external partners to support regulatory reporting processes.

• Participate in continuous improvement initiatives and departmental projects.

• Ensure all activities are completed in accordance with established procedures, quality standards and regulatory requirements.

Requirements

• A bachelor's degree at NFQ Level 8 or equivalent in Science, Engineering, Law, a clinical discipline or a related field.

• Previous experience in a medical device, pharmaceutical or other regulated environment is desirable.

• Approximately 1–2 years of relevant experience is advantageous, although candidates with limited experience will also be considered.

• A basic understanding of anatomy, physiology and medical terminology.

Key Skills

• Excellent attention to detail and strong documentation skills.

• Analytical thinking and problem-solving abilities.

• Strong written and verbal communication skills, with fluency in English.

• Ability to work collaboratively with cross-functional teams.

• A proactive approach to learning, accountability and continuous improvement.

• A strong commitment to quality, ethical standards and patient safety.

What's on Offer?

• A 12-month contract with the possibility of extension.

• An opportunity to gain valuable experience in medical device regulatory affairs and vigilance.

• Exposure to complaint investigations, post-market surveillance and regulatory reporting.

• The opportunity to develop specialist knowledge within a highly regulated industry.