Quality/ Regulatory Specialist, Medical Devices

Capio Spine Center Stockholm; Liverpool; On-site; GBP 35,000 - 55,000; Full time

Job summary

A leading Medical Devices company based in Liverpool seeks an experienced QA/RA Officer for their R&D facility. The role involves ensuring compliance with ISO standards, managing quality and regulatory documentation, and collaborating with various departments. Candidates should possess a degree in Life Science and have relevant QA/RA experience, particularly in the IVD sector.

Benefits

Parking onsite

Private medical insurance

Life assurance

Company pension

Qualifications

• Minimum educated to Degree level in a Life Science (Biomedical, Microbiology, Biotechnology, etc).
• Previous QA/RA experience with IVD/Diagnostics sector preferred.
• Strong report writing and communication skills required.

Responsibilities

• Maintain compliance with ISO standards and regulatory requirements.
• Investigate complaints and ensure corrective actions are documented.
• Oversee document control, audits, and maintain training records.

Skills

Report Writing

Communication

ISO Standards Knowledge

IT Proficiency

Education

Degree in Life Science

Job description

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 134845, 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.

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