Description
IVD Regulatory Affairs Scientist
Location: Craigavon
Hours: 37.5 hours per week
Salary: Competitive plus excellent benefits package
Business Unit: Almac Diagnostics
Ref No.: HRJOB11586
The Role
Almac Diagnostics is at the forefront of developing innovative diagnostic solutions that support precision medicine and improve patient outcomes globally. Our Regulatory Affairs team plays a critical role in ensuring that our diagnostic products meet global regulatory requirements and can be successfully delivered to patients and partners worldwide.
In this role, you will support the regulatory aspects of in vitro diagnostic (IVD) projects, including the preparation and submission of regulatory applications, coordination of global registrations, and ensuring compliance with evolving international regulations. You will also play a key role in IVDR Health Institution Exemption (HIE) activities and clinical trial regulatory compliance across EU, UK, US and international markets.
This is a highly collaborative and technically focused role, requiring strong regulatory knowledge, attention to detail and the ability to manage multiple priorities within a fast-paced environment.
Key Responsibilities
* Coordinate and manage global regulatory submissions (EU, FDA and international), including dossier preparation and electronic submission publishing
* Support the development of regulatory strategies and global product registrations
* Assist in the preparation and review of labelling, IFUs and regulatory documentation to ensure compliance
* Maintain communication with Regulatory Authorities and support responses to queries during application reviews
* Support lifecycle management activities for approved products, including post-approval regulatory updates
* Perform regulatory risk assessments in response to new and updated regulations
* Support IVDR Health Institution Exemption (Article 5(5)) activities, including GSPR documentation and in-house device compliance
* Prepare and submit Clinical Performance Study Plans (CPSPs) and regulatory applications to EU Competent Authorities and Ethics Committees
* Support regulatory compliance for clinical trials, including MHRA combined review processes and IVDR/CTR requirements
* Assist with FDA regulatory submissions (e.g. IDE, PMA) and QMSR/ISO 13485 alignment activities
* Contribute to China/APAC regulatory submissions, including NMPA and HGRAC requirements
* Collaborate cross-functionally to communicate regulatory requirements and support business objectives
* Monitor evolving global regulatory frameworks and assess impact on operations
Quality & Compliance
* Perform all duties in line with Almac Diagnostic Services SOPs and Quality Management Systems
* Ensure compliance with applicable regulations and standards (e.g. ISO15189, ISO13485, GCP, CAP/CLIA)
* Support Quality Assurance and regulatory compliance activities to ensure Right First Time delivery
* Maintain accurate and compliant documentation across all regulatory processes
Key Requirements
* Degree (BSc or equivalent) in a Life Science or related discipline
* Significant regulatory affairs experience within the IVD industry
* Strong knowledge of EU and US IVD regulatory frameworks
* Excellent communication and organisational skills
Paid Time-Off for Vacation and Sick Days
Almac Group is an Equal Opportunity Employer
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