Quality/ Regulatory Specialist, Medical Devices

Russell Taylor Group Ltd; Liverpool City Region; On-site; GBP 35,000 - 50,000; Full time

Job summary

Une entreprise spécialisée dans les dispositifs médicaux recherche un spécialiste qualité/réglementaire. Situé à Liverpool, ce poste implique la conformité avec les normes ISO et des responsabilités en affaires réglementaires. Le candidat idéal aura une formation en sciences de la vie et de l'expérience dans le secteur IVD.

Benefits

Stationnement sur place

Assurance santé privée

Assurance vie

Pension d'entreprise

Qualifications

• Diplôme minimum de niveau universitaire en sciences de la vie.
• Expérience antérieure en QA/RA requise.
• Bonne compréhension des normes ISO 9001, 17025.

Responsibilities

• Maintenir la conformité avec les normes de qualité ISO.
• Enquêter sur les plaintes et assurer l'action corrective.
• Préparer des documents pour l'expédition mondiale des produits.

Skills

Rédaction de rapports

Compétences communicationnelles

Conformité ISO

Education

Diplôme en sciences de la vie (Biomedical, Microbiology, Biotechnology, etc.)

Job description

Quality/ Regulatory Specialist, Medical Devices

Quality/ Regulatory Specialist, Medical Devices

Based in Liverpool
Permanent
Monday - Friday 8:30am - 4.30pm
Competitive salary
Parking onsite, private medical, life assurance, company pension

Our Client, an established Medical Devices company / IVD are looking to recruit for an additional experienced QA/RA Officer to work at their modern R&D facility based on the outskirts of Liverpool. The role also includes additional duties across Regulatory Affairs in relation to Medical Device regulations.

Duties:

• Working closely with the QARA Manager and Team Leader, maintaining compliance with applicable ISO Quality standards (ISO13485 and ISO9001) and the regulatory and statutory requirements of the IVDR, necessary for the continued business activities of the Client.
• Investigation into complaints received, ensuring corrective action and preventive measures are identified, documented and actioned, in line with QMS requirements.
• Involvement in all other QMS requirements, including Internal audits, document control, Qualification and Validation projects, change control, Supplier approval, monitoring and re-evaluation
• Oversee and maintain portals for training records and equipment calibration records.
• Work with R&D staff in the compilation/storage and accessibility of product technical documentation in accordance with applicable regulatory requirements (IVDR / UKCA).
• Ensure Client products are registered in accordance with relevant national requirements for UK and also for Global use, as required.
• Provide advice/guidance to departments in regulatory matters.
• Create relevant paperwork required to support global shipment of manufactured product.
• Investigate and action ad-hoc global regulatory enquiries and provide necessary documentation.
• Preparation of written reports and documentation.
• In addition to the specified duties the Quality Assurance and Regulatory Affairs Specialist is expected to perform additional tasks that the company may require.

Qualification and Experience:

• Minimum educated to Degree level in a Life Science (Biomedical, Microbiology, Biotechnology, etc) subject.
• Previous QA/ RA experience
• A solid understanding of ISO (phone number removed), 9001, 17025 standards and working to these QMS.
• The ideal applicant will have worked in the IVD/ Diagnostics sector.
• The ideal Candidate will have previous regulatory experience.
• Experience in raising non conformances, CAPAs etc
• Strong report writing skills, and communicative skills required.
• Will be IT proficient working across a range of software's and applications.

Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or GDPR please get in touch with us

Job Info

Job Title:

Quality/ Regulatory Specialist, Medical Devices

Company:

Russell Taylor Group Ltd

Location:

Liverpool, Merseyside

Posted:

Closes:

Jul 18th 2025

Sector:

Medical, Pharmaceutical & Scientific

Contract:

Permanent

Hours:

Full Time

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