Associate MDR & Vigilance Specialist

Duration: 23 months

Job Type: Hybrid (2 days onsite, 3 days remote)

About the Role:

An exciting opportunity for a dynamic Associate MDR & Vigilance Specialist to ensure top safety and

compliance standards for medical devices, especially pacemaker products.

Key Responsibilities:

• Complaint Handling: Coordinate and document incoming complaints.

• Investigation: Lead investigations to determine root causes.

• Regulatory Compliance: Maintain and report Medical Device Reports (MDRs).

• Agency Queries: Respond to regulatory agency queries.

• Risk Management: Support risk and health hazard analysis.

• Continuous Improvement: Contribute to CQXM department initiatives.

Key Skills & Experience:

• Education: Bachelor's degree (Level 8 NFQ) in Engineering, Science, Legal, Clinical, or related discipline.

• Experience: 1-2 years in medical devices or related fields.

• Critical Thinking: Strong decision-making skills.
• Attention to Detail: Exceptional precision in work.

• Technical Expertise: Experience in technical, clinical, or regulatory fields.

• Communication: Excellent written and verbal skills; collaborative.

• Medical Knowledge: Basic anatomy, physiology, and medical terminology.

• Customer Focus: Commitment to patient safety and customer service.

Additional Responsibilities:

• Monitor and manage drug or device surveillance programmes.

• Resolve legal liabilities and ensure regulatory compliance.

• Review clinical databases for ADE data.

• Liaise with internal and external collaborators for regulatory reporting.

Specialist Career Stream:

• Autonomy: Entry-level role with close supervision.

• Impact: Deliver smaller, less complex projects.

• Problem-Solving: Address straightforward issues.

• Communication: Internal group interactions.

• Self-Development: Focus on personal growth; potential to mentor. Required Knowledge and Experience:

• Advanced education with broad theoretical knowledge.

Community and Quality of Life:

County Galway, Ireland, offers a vibrant community with a high quality of life, stunning landscapes, and rich

cultural heritage.

Join the Team:

Apply today to make a meaningful impact in the medical devices industry and work with a passionate team dedicated to excellence and innovation.

Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters.

For further information on this role please contact Hannah Doyle on 086 107 0950 Engineering@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.