Regulatory Affairs Specialist

1w1 week ago

LGC Group

Ballina, IE · Full-time · €50,000 – €65,000

About this role

Technopath Clinical Diagnostics, part of LGC Clinical Diagnostics, develops and manufactures diagnostic quality solutions for life sciences laboratories. This hands-on regulatory role supports product compliance, patient safety, and business continuity. Expertise combines with robust quality systems and values of passion, curiosity, integrity, brilliance, and respect.

As Regulatory Affairs Specialist, partner closely with Quality, R&D, and Operations to apply requirements across the in-vitro diagnostic portfolio. Sustain CE marking, support IVDR activities, and ensure ongoing compliance within a well-established quality system. Regulatory judgement drives real impact in daily decisions.

Own day-to-day regulatory activities with a practical, business-focused approach to IVDD and IVDR. Act as Person Responsible for Regulatory Compliance (PRRC) per IVDR Article 15, fulfilling duties independently with integrity. Remain available for oversight and decision-making without disadvantage.

Contribute to full product lifecycle through risk management per ISO 14971, Post-Market Surveillance assessments, and labelling reviews. Provide input to Competent Authorities and support global submissions. Collaboration is embedded, valuing expertise in a supportive environment.

Requirements

Expertise in applying IVDD and IVDR requirements to in-vitro diagnostics
Experience preparing and maintaining Technical Documentation for CE marking
Knowledge of EU Directives, ISO standards, FDA guidance, and 21 CFR
Competence to act as PRRC per IVDR Article 15
Familiarity with ISO 14971 risk management for medical devices
Understanding of Post-Market Surveillance (PMS) and reporting for IVDs
Ability to review product labelling for regulatory compliance

Responsibilities

Implement and support CE marking activities consistent with IVDD / IVDR
Prepare, update and maintain Technical Documentation / Technical Files for EU and selected global markets
Coordinate product registrations, notifications and certifications, ensuring records remain current and accurate
Own and maintain a complete, up-to-date library of relevant EU Directives, ISO standards, FDA guidance and 21 CFR requirements
Fulfil PRRC responsibilities in accordance with IVDR Article 15
Provide regulatory review and approval for changes impacting the Quality Management System
Support risk management activities in line with ISO 14971 principles
Perform Post-Market Surveillance (PMS) assessments and support associated reporting obligations

Benefits

Contribute directly to improved patient outcomes
Work in a culture shaped by passion, curiosity, integrity, brilliance and respect
Regulatory decisions with real impact on business continuity
Collaboration embedded across Quality, R&D and Operations teams