At a Glance
- Tasks: Support regulatory aspects of innovative diagnostic projects and ensure compliance with global regulations.
- Company: Join Almac Diagnostics, a leader in precision medicine and diagnostic solutions.
- Benefits: Competitive salary, excellent benefits package, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on quality and compliance.
- Why this job: Make a real impact in healthcare by ensuring diagnostics reach patients worldwide.
- Qualifications: Degree in Life Science and experience in IVD regulatory affairs required.
The predicted salary is between 40000 - 50000 £ per year.
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. We currently have an opportunity to join our Regulatory Affairs team in the role of IVD Regulatory Affairs Officer. 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
How to apply
Apply online and tailor your CV to outline how you meet the role criteria. Please upload your CV in PDF format where possible.
Closing Date
Closing date for receipt of applications 7th June 2026 at 17:00
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role by our Talent Acquisition team. Speculative candidate CVs received or submitted directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
IVD Regulatory Affairs Scientist in Craigavon employer: Almac Group
Almac Diagnostics is an exceptional employer, offering a dynamic work environment in Craigavon where innovation meets collaboration. With a strong focus on employee growth and development, we provide comprehensive training and support to ensure our team members excel in their roles. Our competitive salary and excellent benefits package reflect our commitment to fostering a rewarding workplace that prioritises the well-being of our employees while contributing to meaningful advancements in precision medicine.
StudySmarter Expert Advice🤫
We think this is how you could land IVD Regulatory Affairs Scientist in Craigavon
✨Tip Number 1
Network like a pro! Reach out to folks in the IVD and regulatory affairs space on LinkedIn. Join relevant groups, attend webinars, and don’t be shy about asking for informational interviews. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for those interviews by brushing up on your knowledge of EU and US IVD regulations. Be ready to discuss how you’ve navigated regulatory challenges in the past. We want to see your expertise shine through!
✨Tip Number 3
Showcase your collaborative spirit! In your conversations, highlight examples of how you’ve worked cross-functionally. This role is all about teamwork, so let us know how you can contribute to our success at Almac Diagnostics.
✨Tip Number 4
Don’t forget to apply through our website! Tailor your CV to reflect your experience in regulatory affairs and IVD projects. A well-crafted application can make all the difference in landing that interview with us.
We think you need these skills to ace IVD Regulatory Affairs Scientist in Craigavon
Some tips for your application 🫡
Tailor Your CV:Make sure to customise your CV to highlight how your experience aligns with the key requirements of the IVD Regulatory Affairs Scientist role. We want to see your relevant skills and achievements front and centre!
Keep It Clear and Concise:When writing your application, clarity is key! Use straightforward language and avoid jargon where possible. We appreciate a well-structured application that gets straight to the point.
Show Your Passion:Let us know why you’re excited about this role and working with Almac Diagnostics. A bit of enthusiasm can go a long way in making your application stand out from the crowd!
Follow Application Guidelines:Don’t forget to upload your CV in PDF format if possible and ensure you apply through our website. Following these guidelines shows attention to detail, which is super important for this role!
How to prepare for a job interview at Almac Group
✨Know Your Regulations
Make sure you brush up on the latest EU and US IVD regulatory frameworks. Being able to discuss specific regulations and how they apply to the role will show that you're not just familiar with the basics, but that you’re genuinely engaged with the field.
✨Prepare for Technical Questions
Expect technical questions related to regulatory submissions and compliance. Review your past experiences and be ready to discuss how you've handled similar situations, especially in fast-paced environments. Use examples that highlight your attention to detail and ability to manage multiple priorities.
✨Show Your Collaborative Spirit
This role is highly collaborative, so be prepared to talk about your experience working cross-functionally. Share specific examples of how you’ve communicated regulatory requirements to different teams and supported business objectives. This will demonstrate your teamwork skills and adaptability.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the team dynamics, ongoing projects, or how the company stays updated with evolving regulations. This shows your interest in the role and helps you gauge if the company culture aligns with your values.
