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Role Filled

Regulatory/Quality Assurance Manager

Medical Devices & Equipment
Regulatory & Compliance
QC/ Regulatory
Sheffield
£48,000 - £52,000

Role Overview

You’ll oversee all regulatory and technical activities across the product range, including Class I, Class I sterile, and Class IIa medical devices. Reporting to senior management, you will play a pivotal role in driving quality standards, regulatory compliance, and operational excellence throughout the business.

Company Information

Zenopa have partnered with a UK-based company specialising in the design and distribution of medical instruments for ear, nose and throat (ENT) professionals. With global operations, they provide disposable and reusable tools tailored to clinical needs, backed by a commitment to quality standards and environmental responsibility.

Role Requirements

Maintain and update the Quality Manual and Product Technical Files.
Lead Internal Audits and manage external Notified Body Audits.
Prepare Clinical Evaluation Reports and Risk Management Reports.
Oversee EtO sterilisation validation and monitoring.
Review biocompatibility testing strategies and safety documentation.
Manage the Class 7 Cleanroom.
Prepare regulatory submissions (MDR certification already achieved).

Person Specifications

Proven experience in regulatory and quality assurance (ideally within the medical device sector, but other highly regulated industries such as pharma, food, or lab may be considered).
In-depth understanding of ISO 13485, MDR, and quality control processes.
Strong analytical and problem-solving skills.
Detail-oriented, highly organised, and collaborative.

Package

Annual bonus (tax-free after 1 year).
Generous holiday: 27 days + bank holidays.
Private medical insurance (after 6 months).
5% employee / 3% employer pension scheme.
Hybrid working (minimum once per week in office).

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Locations

Alfreton
Barnsley
Birkby
Bradley
Burton upon Trent
Buxton
Cheadle
Chesterfield
Cleethorpes
Deighton
Derby
Dewsbury
Doncaster
Dronfield
Grimsby
Huddersfield
Hyde
Macclesfield
Mansfield
Matlock
Newark
Normanton
Nottingham
Pontefract
Rotherham
Scunthorpe
Sheffield
Stockport
Sutton-in-Ashfield
Wakefield
Previous Listing
Date Updated
03 Jul 2025
Job reference
74668
Categories
Full Time
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