Quality and Regulatory Associate Job Description
Reports to: QA/RA Director
Location: Remote (Transitioning to Hybrid)
Status: Full Time, Ireland-based only
Work Eligibility
This role requires full work authorization in Ireland. No visa sponsorship available. Candidate must be located in Ireland.
About Comply Guru
Comply Guru delivers transformative regulatory and quality training within the Life Sciences industry. Our mission is to raise the standard of regulatory and QMS competence globally through structured, practical, accredited learning solutions. We are now seeking a high‑potential Quality and Regulatory Associate to join our team.
This role is designed as a structured development pathway for an early‑career regulatory professional who demonstrates strong analytical ability, professional maturity, ownership, initiative, and the drive to grow into independent regulatory responsibility.
Role Purpose
The Quality and Regulatory Associate will support the QA/RA Director in maintaining regulatory content accuracy, supporting accreditation activities, strengthening our ISO 9001 Quality Management System, and contributing to strategic projects across the business.
The primary objective during the probationary period is to assess and develop the core professional behaviours required for long‑term success within Comply Guru, including:
Ownership of assigned activities
Initiative and proactive engagement
Communication and stakeholder management
Accountability and follow‑through
Ability to work independently within a remote environment
Quality and accuracy of output
The successful candidate will receive structured exposure to:
ISO 13485
FDA QMSR
MDSAP
EU MDR
EU IVDR
Accreditation frameworks (CQI/IRCA, RAPS, Exemplar Global)
ISO 9001 Quality Management Systems
Following successful completion of probation, additional development pathways may be available including Instructor Development, Auditor Development and Subject Matter Specialization.
Key Responsibilities
Regulatory Affairs
Support review and update of regulatory training material (MDR, IVDR, MDSAP, FDA, QMSR, ISO 13485)
Monitor regulatory updates and assist in impact analysis
Prepare documentation and evidence of audits and accreditation renewals
Support maintenance of Approved Training Partner status
Assist during drafting structured regulatory communications/content
Quality Management System
Quality Management System
Support implementation and continual improvement of ISO 9001
Maintain controlled documents and records
Participate in internal audit activities
Support CAPA and continual improvement initiatives
Contribute to the Quality Objectives and Business Improvement Projects
Projects and Business Operations
Utilize company project management systems to manage assigned activities
Support strategic business projects
Develop learner support resources and guidance documents
Contribute to Reference Materials
Contribute to blogs, articles and thought leadership activities
Support project planning, scheduling and reporting activities
Identify opportunities for process improvement and operational efficiency
Training & Learning Support
Observe training programmes to develop regulatory and quality knowledge
Support maintenance and improvement of training materials
Assist with learner support activities
Participate in structured Instructor Development following successful completion of probation where appropriate
Experience & Development Pathway
We are open to candidates across the following experience levels within the defined salary band.
€45,000: Entry Level Regulatory Associate
Minimum 2 years’ experience in a regulated environment (MedTech, pharma, QA/QC, RA support)
Strong academic foundation in science / engineering / quality
High analytical capability
Demonstrated attention to detail
Will require structured mentoring across regulatory frameworks
€50,000: Developing Regulatory Professional
3-5 years’ relevant QA/RA experience
Practical exposure to ISO 13485 or FDA QSR/QMSR
Experience supporting audits or documentation preparation
Able to contribute independently to defined tasks with guidance
€55,000: Advanced Junior / Near‑Independent Contributor
5 or more years’ experience in regulated industry
Hands‑on QMS or regulatory documentation experience
Able to lead defined regulatory workstreams with limited oversight
Experience interacting with auditors or accreditation bodies
Essential Attributes (Across All Levels)
Exceptional written communication skills
Structured and analytical thinking
Strong organizational discipline
Professional maturity and discretion
Willingness to receive mentoring and constructive feedback
High personal accountability
Comfortable working in a fast‑growing environment
Probation Success Criteria
Successful completion of probation will be assessed against:
Ownership of assigned activities
Initiative and proactive engagement
Quality and accuracy of work
Communication and stakeholder management
Ability to work independently
Professional conduct and maturity
Effective use of company systems and processes
Contribution to projects and business objectives
Ability to operate effectively within a remote working environment
Development Pathways
Following successful completion of probation, the QA/RA Associate may be considered for further development in one or more of the following pathways:
Instructor Development Pathway
Auditor Development Pathway
Progression within these pathways will be based on demonstrated performance, business requirements, and individual career aspirations.
Professional Development Investment
In addition to Pension, Bonus, and Healthcare (where applicable), Comply Guru provides significant investment in professional development.
This includes structured development aligned to:
Recognized, accredited and certified regulatory training (Estimated investment value: €5,000 - €10,000)
ISO 13485, FDA QMSR, MDSAP, EU MDR, EU IVDR, Lead Auditor and related Regulatory Certifications (where appropriate)
Preferred Qualifications
Bachelor’s degree in science, Engineering, Quality, or a related discipline (beneficial)
Recognized training in Quality and Regulatory Affairs e.g. CQI-IRCA Certified MD-QMS Lead Auditor, MDSAP, MDR, or equivalent (beneficial)
Train the Trainer certification (beneficial)
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