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 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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