Quality and Regulatory Specialist

taylorollinson Ltd; United Kingdom; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading life sciences company in Buckinghamshire is seeking a Quality Assurance & Regulatory Affairs Specialist. This permanent role involves maintaining compliance with key quality standards like ISO 9001 and ISO 13485 while ensuring regulatory adherence. The successful candidate will play a vital role in the company's operations, contributing to continuous improvement in quality and environmental management.

Qualifications

• Prior industry experience in Quality and Regulatory role within Medical Device or Diagnostics sector.
• In-depth knowledge of ISO 13485, ISO 9001, and ISO 17025.
• Experience with ISO-accredited audits.

Responsibilities

• Implement quality and regulatory directives to ensure compliance.
• Maintain the company's Quality Management Systems (QMS).
• Ensure regulatory compliance for in vitro diagnostics.

Skills

Quality Management Systems

ISO 13485

ISO 9001

ISO 17025

Environmental Management Systems

Job description

Quality Assurance & Regulatory Affairs Specialist

Location: Buckinghamshire

Our client is an established life sciences business based in Buckinghamshire. They distribute and manufacture high-quality and innovative products, including in-vitro diagnostics, laboratory reagents, and biological materials, across the European life sciences market.

An opportunity has become available for an experienced Quality Assurance and Regulatory Affairs Specialist to join the company on a permanent basis.

This is an onsite position, so the successful applicant will be expected to work full-time on site.

The Role:

This is a key role within the Quality and Regulatory team. The core responsibility is to act as the responsible person for the Company ISO 9001, ISO 13485, and ISO 14001 Environmental Management Systems, and ensure continuous improvement in quality and environmental standards.

• Implement quality and regulatory directives to ensure compliance.
• Maintain the company's Quality Management Systems (QMS) in line with ISO 9001, ISO 13485, and ISO 17025.
• Ensure regulatory compliance for in vitro diagnostics – IVDD/IVDR and CE marking.
• Schedule audits in accordance with ISO 13485, ISO 9001, and ISO 17025.
• Support the management of non-conformities and deviations.

Suitable Applicants:

We are seeking candidates with prior industry experience in a Quality and Regulatory role within the Medical Device or Diagnostics sector.

Key requirements include:

• Proven experience in maintaining Quality Management Systems.
• In-depth knowledge of ISO 13485, ISO 9001, and ISO 17025.
• Experience with ISO-accredited audits.
• Prior experience with Environmental Management Systems.

In return, our client offers a permanent role with a salary of circa £40,000-£60,000 (dependent on experience) and benefits.

I'm interested in this job

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