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Quality & Regulatory Manager UK & Ireland
Scientific Supplier
Regulatory & Compliance
IVD & Industry
Basingstoke
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Role Overview
In this role, you will take ownership of the regional Quality Management System and oversee regulatory activities to maintain compliance with national and international standards. You will lead a small team, manage interactions with regulatory authorities, and act as a key partner to operational, commercial, and corporate functions. This role combines strategic leadership with hands-on oversight, ensuring that quality culture is embedded throughout the organisation and that products and processes meet customer, regulatory, and corporate expectations.
Company Information
A global leader in diagnostic solutions is seeking a Quality & Regulatory Manager to oversee quality operations and regulatory compliance across the UK & Ireland region. This is a high-impact leadership role supporting both regional business goals and broader corporate quality initiatives. You will work closely with senior stakeholders across Europe and the UKI cluster to ensure that quality systems, regulatory processes, and customer-focused practices are effectively implemented and continually improved.
Role Requirements
Lead, mentor, and develop the UKI Quality & Regulatory team, ensuring effective delivery of quality and compliance activities.
Drive regional quality objectives and lead continuous improvement initiatives across the cluster and its subsidiaries.
Oversee quality, regulatory, and vigilance processes, ensuring adherence to corporate policies, regulatory frameworks, and planned project milestones.
Act as the primary contact for local regulatory authorities, particularly regarding field safety actions and other regulatory notifications.
Maintain a robust Quality Management System aligned with corporate standards and applicable regulations, including those related to distributors.
Streamline and harmonise processes to enhance efficiency, reduce complexity, and support a strong customer-focused quality culture.
Partner with business functions to embed quality principles in daily operations and decision-making.
Define and monitor KPIs to assess process performance, guiding stakeholders in root-cause analysis and action planning.
Ensure internal and supplier audits are planned, resourced, and executed, including the qualification of internal auditors.
Person Specifications
Bachelor’s degree in a life science discipline or equivalent relevant industry experience.
Strong working knowledge of UK regulatory expectations, including experience engaging with MHRA or similar authorities.
A master’s qualification in quality or related disciplines is advantageous.
Demonstrated leadership skills with the ability to influence, communicate, and partner effectively across functions.
Proven experience managing audits and ensuring compliance with standards such as ISO 9001, ISO 14001, and ISO 45001.
Package
Basic
20% bonus
Car/car allowence
PHI
Pension
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Locations
Aldershot
Amersham
Andover
Aylesbury
Banbury
Barnet
Basingstoke
Bicester
Borehamwood
Bracknell
Brent
Camberley
Camden
Chertsey
Chessington
Chippenham
City of London
Clapham
Ealing
Eastleigh
Egham
Epsom
Faringdon
Fulham
Greenford
Guildford
Harrow
Hayes
Hemel Hempstead
High Wycombe
Islington
Kingston-upon-Thames
Leatherhead
Maidenhead
Malmesbury
Marlow
Newbury
North West London
Northolt
Oxford
Pinner
Putney
Radlett
Reading
Richmond upon Thames
Rickmansworth
Romsey
Ruislip
Sailsbury
Slough
South West London
Southall
Southampton
Staines
Swindon
Twickenham
Wandsworth
Watford
Wembley
West Central London
West London
Westminster
Wimbledon
Winchester
Windsor
Witney
Woking
Wokingham
Date Updated
04 Dec 2025
Job reference
75355
Categories
Full Time
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