assurance manager Work, Jobs in craigavon, arm (with Salaries)

IVD Regulatory Affairs Scientist
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IVD Regulatory Affairs Scientist

Almac Group -
Craigavon

Apply Now

Job details

Permanent | Full-time
8 days ago

Qualifications

Bachelor's degree
Organisational skills
Communication skills

Full job 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.

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

Essential:

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.

Apply Now

Refine Your Search

assurance manager jobs in craigavon, arm

IVD Regulatory Affairs Scientist

Customer Service Sales Advisor

VacancyTitle: Technical Officer

Quality Inspector

VacancyTitle: Production Shift Manager - Evenings

Technical Officer

Production Administrator

Manager, People Consulting, Belfast, Derry, Londonderry

Programme Manager

Supply Chain Manager

Production Shift Manager

Business Process Analyst - Northern Ireland (Site based)

VacancyTitle: Apprentice Engineer-Northern Ireland

Building Services Manager - Midlands

Despatch Operator (Evening Shift)

Production Operative

Communication Manager

Financial Accountant

Manager, Operational Due Diligence, Strategy & Execution, EY Parthenon, Belfast or Derry,Londonderry

Senior Client Onboarding Officer

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