Regulatory Affairs Specialist
We are seeking a dedicated Regulatory Affairs Specialist to join our team in Tipperary, Ireland.
This is an exceptional opportunity to work with a world-class team committed to maintaining our flawless reputation in the IVD industry.
You will play a key role in ensuring our products meet the highest regulatory standards globally.
The role involves supporting regulatory compliance and product registration activities, both within the EU and internationally, with a strong focus on IVDR requirements, quality systems, and documentation.
You will also provide regulatory input across cross-functional teams and ensure compliance with applicable standards and regulations.
Key Responsibilities:
* Implement CE marking and IVDR-related activities, ensuring timely completion of required tasks and deliverables.
* Maintain and update status of product registrations and notifications, including documentation and certifications for internal and external requests.
* Prepare and submit product registration documentation for non-EU markets.
* Maintain current listings of applicable EU standards, Directives, FDA CFRs, and guidance documents; ensure Technopath's awareness and compliance.
* Provide regulatory input and approval for changes impacting the Quality Management System (QMS).
* Assist in the preparation and maintenance of Technical Files for submission to EU and international regulatory bodies.
* Contribute to Post Market Surveillance and Risk Management processes.
* Support Manufacturing QA, R&D Quality, and Quality Systems from a regulatory and quality perspective.
* Approve and release customer-facing labelling (IFUs, kit & vial labelling), ensuring compliance with applicable regulations and standards.
* Ensure adherence to quality system requirements per FDA QSRs, ISO 13485, and other relevant market regulations.
* Uphold Health and Safety standards and maintain designated areas to good housekeeping standards.
* Perform additional duties as required to support quality systems.
Requirements
Qualifications:
* Minimum of a degree qualification in a relevant Science, Engineering, or Quality Assurance field.
* 3+ years' experience working in a regulated medical device/in vitro medical device environment.
Skills:
* Detailed knowledge of FDA 21CFR820, ISO 13485, IVDD98/79/EC, IVDR EU/2017/746, and international regulatory requirements.
* Familiarity with ISO 14971.
Personal Qualities:
* Strong interpersonal skills and the ability to communicate well both verbally and in writing.
* Excellent attention to detail and ability to prioritize tasks effectively.
* Strong initiative and proven troubleshooting skills required.
Benefits
Our Offer:
* 25 days holidays
* Life assurance & health allowance
* Discounts with local and national retailers
* Free 24/7 Employee Assistance Programme
* Recognition schemes and monetary awards
About Us:
We foster a culture of inclusion and collaboration. We believe that diverse perspectives lead to better outcomes and encourage applicants from all backgrounds to apply.