Back Posted: Jun 21 2025

Quality Assurance & Regulatory Affairs Manager

Buckingham, Buckinghamshire , United Kingdom

Health Care & Medicine jobs >> Pharmaceutical

Negotiable

Permanent

Name Confidential

Description

Quality Assurance & Regulatory Affairs Manager
Location: Buckinghamshire
Sector: Life Sciences
Salary: circa £65,000
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 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

No. of positions available*: 1
Salary: Negotiable
Experience: None
Education: None
Post Date: June 21, 2025
Job id:. CV-42401
Position Type: Permanent
Applicants: 0
Views: 2

Refer $50 Save job Free resume review Apply Now

Alert me to new jobs like this: Health Care & Medicine jobs in city Buckingham

Email address

Create alert

By continuing your agreeing to our term and conditions

Find us at:

Never provide bank account, credit card details or any other financial information, or make any form of payment, when applying for a job. If you are ever asked to do this by a recruiter on Pure Jobs please click the Report button or contact us with the advertiser's company name and the title of the job vacancy. You should not send any money to anyone. A genuine employer with a job offer would never ask you to do this.

Report this job

Report a job

If you're concerned about a job advert, let us know and our quality team will investigate.

Your name(*)

Invalid Input

Your email address(*)

Invalid Input

Please select you reason(*)

Additional information(*)

Invalid Input

Quality Assurance & Regulatory Affairs Manager

Description

Find us at:

Report a job

Related Search:

Name Confidential

Job Seeker //

Employer //

About Us //

Follow //

PLEASE NOTE! WE USE COOKIES AND SIMILAR TECHNOLOGIES FOR THE BEST USER EXPERIENCES

Sign in to your account

Quality Assurance & Regulatory Affairs Manager

Description

Find us at:

Report a job

Related Search:

Name Confidential

Similar Jobs

More jobs from this company

Job Seeker //

Employer //

About Us //

Follow //

Subscribe to updates from our blog

PLEASE NOTE! WE USE COOKIES AND SIMILAR TECHNOLOGIES FOR THE BEST USER EXPERIENCES