Quality and Regulatory Associate

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: Advance 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
• This includes structured development aligned to: ISO 13485, FDA QMSR, MDSAP, EU MDR, EU IVDR, Lead Auditor and related Regulatory Certifications (where appropriate)

At Comply Guru, we do not just employ quality and regulatory professionals, we develop them.

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)