Quality/ Regulatory Specialist, Medical Devices

Capio Spine Center Stockholm; Liverpool; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading company in the medical devices sector is looking for a Quality/Regulatory Specialist to join their team in Liverpool. This role will involve ensuring compliance with ISO standards and regulatory requirements, as well as managing quality assurance processes. Ideal candidates will have a degree in Life Sciences and prior experience in a related QA/RA role, along with strong report writing and communication skills.

Benefits

Parking onsite

Private medical

Life assurance

Company pension

Qualifications

• Minimum educated to Degree level in a Life Science (Biomedical, Microbiology, Biotechnology, etc).
• Previous QA/RA experience is essential.
• Strong report writing and communication skills are required.

Responsibilities

• Maintaining compliance with ISO standards and regulatory requirements.
• Investigate complaints and ensure corrective actions are documented.
• Oversee training records and equipment calibration.

Skills

Report Writing

Communication

Problem Solving

Education

Degree in Life Science

Job description

Quality/ Regulatory Specialist, Medical Devices

Join to apply for the Quality/ Regulatory Specialist, Medical Devices role at Capio Spine Center Stockholm

Quality/ Regulatory Specialist, Medical Devices

1 day ago Be among the first 25 applicants

Join to apply for the Quality/ Regulatory Specialist, Medical Devices role at Capio Spine Center Stockholm

Get AI-powered advice on this job and more exclusive features.

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.

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 Privacy Policy 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 here.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Manufacturing

• Industries

  Manufacturing

Referrals increase your chances of interviewing at Capio Spine Center Stockholm by 2x

Get notified about new Quality Specialist jobs in Liverpool, England, United Kingdom.

Merseyside, England, United Kingdom 15 hours ago

Merseyside, England, United Kingdom 5 days ago

Warrington, England, United Kingdom 16 hours ago

Chorley, England, United Kingdom 4 hours ago

Liverpool, England, United Kingdom 5 days ago

Runcorn, England, United Kingdom 4 days ago

Broughton, England, United Kingdom £23.84-£31.54 2 weeks ago

Runcorn, England, United Kingdom 1 week ago

Liverpool, England, United Kingdom 1 week ago

Wrexham, Wales, United Kingdom 2 hours ago

Chester, England, United Kingdom 3 weeks ago

St Asaph, Wales, United Kingdom 1 day ago

Northwich, England, United Kingdom 1 month ago

Rainford, England, United Kingdom 2 days ago

Warrington, England, United Kingdom 2 days ago

Warton, England, United Kingdom 1 week ago

Senior advisor - Continuous water quality monitoring programme - 31091

Warrington, England, United Kingdom 4 hours ago

HSE and Quality Systems Engineer - Construction

Senior advisor - Continuous water quality monitoring programme - 31091

Winsford, England, United Kingdom 4 hours ago

Senior advisor - Continuous water quality monitoring programme - 31091

Leyland, England, United Kingdom 4 hours ago

Liverpool, England, United Kingdom 2 days ago

Chorley, England, United Kingdom 1 day ago

Primary Care Network Pharmacy Technician

Liverpool, England, United Kingdom 5 days ago

Liverpool, England, United Kingdom 1 week ago

Liverpool, England, United Kingdom 2 days ago

Bucklow Hill, England, United Kingdom 3 weeks ago

Heswall, England, United Kingdom 4 days ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.