At a Glance
- Tasks: Prepare and maintain technical documentation for innovative diagnostic products.
- Company: Fortress Diagnostics Ltd, a leader in the IVD industry.
- Benefits: Company pension, private healthcare, ongoing training, and career development.
- Other info: Gain experience in a regulated environment with excellent career growth opportunities.
- Why this job: Join a dynamic team and make an impact in quality assurance and regulatory affairs.
- Qualifications: Strong attention to detail, organisational skills, and good IT proficiency.
The predicted salary is between 30000 - 40000 £ per year.
Location: Antrim, Northern Ireland
Job Type: Full-time
Department: Quality Assurance (QA), Quality Control (QC) & Regulatory Affairs
About the Role
Fortress Diagnostics Ltd is looking for a highly organised and detail-oriented Technical Documentation & Quality Coordinator to join our growing Quality and Regulatory team. This is an excellent opportunity to work within the in vitro diagnostics (IVD) industry, supporting the preparation of technical documentation, quality systems, and regulatory submissions for products distributed worldwide. You will work closely with our QA, QC, Regulatory Affairs, Manufacturing, and R&D teams to ensure product documentation is accurate, compliant, and maintained to the highest standards.
Key Responsibilities
- Prepare, review, and maintain Instructions for Use (IFUs), Safety Data Sheets (SDS/MSDS), product labels, and technical documentation.
- Assist with the preparation and maintenance of IVDR technical files.
- Compile documentation required for CE marking, product registrations, and regulatory submissions.
- Support customer registration documentation for international distributors.
- Maintain controlled documents within the Quality Management System (QMS).
- Assist with document control, change control, CAPAs, and quality records.
- Support internal, customer, and regulatory audits.
- Work with QC and R&D teams to compile validation, verification, stability, and performance data.
- Ensure documentation complies with ISO 13485, IVDR, and other applicable regulatory requirements.
- Coordinate updates to product documentation and maintain revision histories.
About You
We are looking for someone who has:
- Excellent attention to detail.
- Strong organisational and administrative skills.
- Excellent written English and document preparation skills.
- Good IT skills, including Microsoft Word and Excel.
- The ability to manage multiple projects and deadlines.
- A proactive attitude and willingness to learn.
Desirable Experience
- Experience working within Quality Assurance, Regulatory Affairs, or a laboratory environment.
- Knowledge of ISO 13485, IVDR, CE marking, or medical devices.
- Experience preparing technical documentation, IFUs, or regulatory submissions.
- A science qualification in Biology, Biomedical Science, Chemistry, or a related discipline would be an advantage.
What We Offer
- Company pension scheme.
- Private healthcare.
- Ongoing training and career development.
- Opportunity to work on innovative diagnostic products used worldwide.
- Opportunity to develop experience in Quality Assurance, Regulatory Affairs, and Medical Device Compliance.
If you are organised, motivated, and enjoy working with technical documentation in a regulated environment, we would love to hear from you. Please submit your CV by clicking the Apply button below.
Technical Documentation & Quality Coordinator TLNT1_NI in Antrim employer: IrishJobs
Fortress Diagnostics Ltd is an exceptional employer located in Antrim, Northern Ireland, offering a dynamic work environment within the in vitro diagnostics industry. With a strong focus on employee growth, we provide ongoing training and career development opportunities, alongside a comprehensive benefits package that includes a company pension scheme and private healthcare. Join us to be part of a collaborative team dedicated to maintaining the highest standards in quality assurance and regulatory compliance for innovative diagnostic products used worldwide.
