Quality Assurance and Regulatory Affairs Manager

Quality Assurance and Regulatory Affairs Manager

Quality Assurance & Regulatory Affairs Manager

Location: Buckinghamshire

Sector: Life Sciences

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 Manager to join the company on a permanent basis. Ideally, this will be an on-site position; however, some hybrid flexibility may be available depending on circumstances.

The Role:

This is a key role within the Quality and Regulatory team, responsible for managing a small team across Production and Quality. Reporting to the Managing Director, the successful candidate will serve as the primary contact and person responsible for Quality and Regulatory Compliance across the business. Key responsibilities include:

• Implementing quality and regulatory directives to ensure compliance
• Maintaining the company's Quality Management Systems (QMS) in line with ISO 9001, ISO 13485, and ISO 17025
• Ensuring regulatory compliance for in vitro diagnostics - IVDD/IVDR and CE marking
• Leading audits in accordance with ISO 13485, ISO 9001, and ISO 17025
• Handling non-conformities and deviations
• Managing a small Quality and Production team to ensure project delivery aligns with company expectations

Suitable Applicants:

Given the responsibilities of this role, we are seeking a candidate with prior industry experience within the Life Science sector in a senior Quality and Regulatory position, demonstrating competencies in the following areas:

• Proven experience in the implementation and maintenance of Quality Management Systems
• In-depth knowledge of ISO 13485, ISO 9001, and ISO 17025
• Experience leading ISO-accredited audits
• Sound knowledge of IVDD and IVDR regulations and CE marking
• Strong communication skills and strategic thinking abilities
• Team management experience with a hands-on leadership approach

In return, our client offers the opportunity to join the company on a permanent basis in a pivotal role. The position offers a salary of circa £65,000 (dependent on experience), along with benefits.

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Compulsory fields are in bold.

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