Senior Risk Manager

Life Science Recruitment; Dublin; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Life Science Recruitment is seeking a Senior Risk Management Engineer/Scientist for a MedTech role in Dublin. You will oversee RMFs across the product lifecycle and provide technical leadership to device program teams.

The role requires ISO 14971:2019, ISO 13485, EU MDR and FDA 21 CFR 820 familiarity, strong FMEA/FTA skills, and ability to mentor junior staff in a global regulatory environment. Hybrid work with competitive salary and benefits.

Qualifications

• Degree-level qualification in Engineering or Science.
• Extensive experience in a regulated MedTech or Pharma environment.
• Strong knowledge of ISO 14971:2019 and ISO 13485.

Responsibilities

• Strategic leadership of Risk Management Files across device programs.
• Execute and oversee FMEA, Fault Tree Analysis, and Medical Hazard Analysis.
• Provide technical expertise for regulatory filings and post-market support.
• Lead process improvements to align with SOTA risk management practices.
• Assess impact of changes, complaints, and CAPAs on risk profiles.

Skills

RMF leadership

FMEA

FTA

ISO 14971

ISO 13485

EU MDR

FDA 21 CFR 820

Regulatory filings

Project mentoring

Education

Engineering or Science degree

Job description

Senior Risk Management Engineer/Scientist – MedTech

Location: Dublin, Ireland (Hybrid - 3 days onsite)

Employment Type: Full-time / Permanent

Role Overview

In this senior-level position, you will be responsible for the integrity of Risk Management Files (RMFs) across the full product lifecycle. You will provide critical technical leadership to Device Program Teams, ensuring that risk assessments are robust, data-driven, and compliant with international standards. This is a highly collaborative role requiring interaction with Quality, Clinical, and Regulatory departments.

Key Responsibilities

• Strategic leadership of Risk Management Files for device and combination product programs.
• Execution and oversight of FMEA, Fault Tree Analysis, and Medical Hazard Analysis.
• Providing technical expertise for global regulatory filings and post-market support.
• Leading process improvements to align with State of the Art (SOTA) risk management practices.
• Assessing the impact of product changes, complaints, and CAPAs on existing risk profiles.

Required Experience

• Degree-level qualification in Engineering or Science.
• Significant experience in a regulated MedTech or Pharma environment.
• Expert knowledge of ISO 14971:2019 and ISO 13485.
• Practical experience with EU MDR and FDA 21 CFR 820 requirements.
• Strong analytical skills with a background in FMEA and FTA methodologies.
• Ability to manage complex projects independently while mentoring junior team members.

Why Join This Organisation?

This is a chance to work at the forefront of medical technology within a global organisation that values technical excellence and patient safety. You will have visibility across the entire product lifecycle and the opportunity to influence design and quality strategies at a high level. The role offers a competitive salary, a comprehensive benefits package, and a flexible hybrid working arrangement.