Comply Guru offer transformative training in the Life Sciences Industry.
We are looking for suitable candidates for a fulltime role as a Regulatory Affairs Specialist.
The ideal candidate will join a team of highly motivated, passionate people who are creating
industry-leading
learning solutions for a global audience.
The Regulatory Affairs Specialist supports the QA/RA Director in ensuring Comply Guru's training programs, processes, and products meet applicable quality and regulatory requirements.
This role focuses on maintaining up to date regulatory content, supporting accreditation activities, and contributing to the implementation and continual improvement of the company's Quality Management System (QMS).
The ideal candidate is detail orientated, organized, and passionate about regulatory compliance, quality standards within MedTech and training.
**This role requires work authorization in Ireland - only apply if authorized to work in Ireland**
This role is a hybrid working position.
High-speed internet connection essential.
Key Responsibilities:
Regulatory Affairs
Support maintenance and development of course content and training materials related to regulatory affairs (e.g., MDSAP, MDR, FDA, QSR/QMSR, ISO *****)
Research and monitor changes to relevant international regulations and standards; assist in updating training materials and internal documentation accordingly
Prepare regulatory documentation and evidence as required for audits, accreditation renewals, and partner reviews (CQI, IRCA, RAPS, Exemplar Global, or equivalent)
Assist in maintaining Comply Guru's accreditation as an Approved Training Partner by ensuring compliance with relevant external bodies
Support communication of key regulatory updates to the QA/RA Director and internal stakeholders.
Quality Management System (QMS)
Assist in implementing, maintaining, and improving the ISO **** based QMS to support certification and compliance objectives
Maintain controlled documents, records, and logs in accordance with quality system procedures
Support internal audit activities and follow-up actions
Participate in CAPA (Corrective and Preventive Action) and continuous improvement initiatives
Training
Collaborate with internal teams and external Subject Matter Experts to ensure regulatory course content remains current, accurate, and compliant
Support development and lead delivery of instructor-led workshops
Provide learner support on regulatory training courses where applicable
General
Maintain professional development to stay current with relevant standards, regulations, and best practices
Support company initiatives, webinars, blogs, and other thought leadership activities related to QA/RA
Perform other duties as assigned by the CEO and/or QA/RA Director
Essential Skills and Experience
Minimum 4 years' experience working within regulated industries (MedTech, QA/RA roles etc.)
Strong understanding of international regulatory frameworks (MDR, MDSAP, FDA QSR/QMSR, ISO *****, ISO ****)
Experience working within a QMS (preferably ISO **** or ISO *****)
Excellent attention to detail and ability to manage multiple projects simultaneously
Strong written and verbal communication skills, with the ability to interpret and communicate complex regulatory information clearly
Competent in MS Office and document control systems
Self-motivated and proactive, with a focus on compliance and quality improvement
Collaborative and team-oriented, with a willingness to learn and take initiative
Strong organizational and problem-solving skills
Committed to maintaining high standards of professional ethics and integrity
Adaptable in a fast-paced, growing business environment
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)
Benefits
Bonus, Healthcare & Pension