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: Enjoy competitive salary, paid time off, and an excellent benefits package.
- Other info: Fast-paced role with opportunities for professional growth and development.
- Why this job: Make a real impact on patient outcomes while working in a collaborative environment.
- Qualifications: Degree in Life Science and experience in IVD regulatory affairs required.
The predicted salary is between 40000 - 50000 £ per year.
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.
IVD Regulatory Affairs Scientist in Craigavon employer: OASIS 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 benefits package, including generous paid time-off and a commitment to work-life balance, makes Almac a rewarding place to build a meaningful career in the rapidly evolving field of diagnostic solutions.
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 professionals in the IVD field on LinkedIn or at industry events. A friendly chat can lead to opportunities that aren’t even advertised yet.
✨Tip Number 2
Prepare for interviews by researching Almac Diagnostics and their recent projects. Show us you’re genuinely interested in our work and how you can contribute to our mission in precision medicine.
✨Tip Number 3
Practice your responses to common regulatory affairs questions. We love candidates who can articulate their experience with EU and US IVD regulations clearly and confidently.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows us you’re serious about joining our team.
We think you need these skills to ace IVD Regulatory Affairs Scientist in Craigavon
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the IVD Regulatory Affairs Scientist role. Highlight your relevant experience in regulatory affairs, especially within the IVD industry, and showcase your knowledge of EU and US regulations.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of your past experiences that align with the key responsibilities mentioned in the job description.
Showcase Your Attention to Detail:In regulatory affairs, attention to detail is crucial. Use your application to demonstrate how you've successfully managed complex regulatory submissions or compliance tasks in the past.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you receive updates directly from us!
How to prepare for a job interview at OASIS 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.
✨Showcase Your Experience
Prepare examples from your past work that highlight your experience in regulatory affairs, especially in IVD projects. Be ready to discuss how you've managed submissions or navigated compliance challenges, as this will demonstrate your hands-on knowledge.
✨Ask Insightful Questions
Come prepared with questions that show your interest in Almac Diagnostics and the role. Inquire about their approach to evolving regulations or how they handle cross-functional collaboration. This not only shows your enthusiasm but also helps you gauge if the company is the right fit for you.
✨Demonstrate Attention to Detail
Since this role requires a keen eye for detail, be prepared to discuss how you ensure accuracy in your work. You might want to share specific strategies you use to maintain compliance and manage documentation effectively, as this will resonate well with the interviewers.
