Company Description
Technopath Clinical Diagnostics, an LGC Clinical Diagnostics company, develops and manufactures a comprehensive portfolio of catalogue and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. Our outstanding team, scientific expertise, efficient operations, and quality systems support a range of advanced technologies daily, improving patient outcomes.
Job Description
We are seeking a dedicated Regulatory Affairs Specialist to join our team in Tipperary, Ireland. We offer the opportunity to work with a world-class team committed to maintaining our flawless reputation in the IVD industry. You will play an important 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 ensures 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 Technopath’s quality systems.
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.
- Detailed knowledge of FDA 21CFR820, ISO 13485, IVDD98/79/EC, IVDR EU/2017/746, and international regulatory requirements.
- Familiarity with ISO 14971.
Additional Information
- 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.
Our values
- PASSION
- CURIOSITY
- INTEGRITY
- BRILLIANCE
- RESPECT
Benefits
- 25 days holidays
- Life assurance & health allowance
- Discounts with local and national retailers
- Free 24/7 Employee Assistance Programme
- Recognition schemes and monetary awards
At LGC, 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. We are an equal opportunity employer and offer reasonable accommodations to individuals with disabilities. If you require any adjustments throughout the recruitment process, please let us know.
Join us in this outstanding opportunity to be part of a company that is leading advancements in the industry!
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