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Quality assurance & regulatory affairs manager

Thame
Veolia | Water Tech
Regulatory affairs manager
€55,000 a year
Posted: 1 April
Offer description

Overview

Veolia Group is a global leader in environmental services, operating across all five continents with nearly 218,000 employees. Specialising in water, energy, and waste management, Veolia Group designs and implements innovative solutions for decarbonisation, depollution, and resource regeneration, supporting communities and industries in their ecological transformation.

Veolia brings together a dedicated team of experienced professionals committed to tackling the world’s most complex challenges related to water scarcity, quality, productivity, and energy. Purite as a business is dedicated to the sustainable management of water, our most vital resource. As part of the Veolia Group, we are committed to innovation, quality, and ecological transformation in water treatment solutions. Our foundation in providing purified water systems spans laboratories, a wide range of industries from food & beverage through to microelectronics and the healthcare market including CSSD, Endoscopy, and Renal departments, with expertise in boxed products through to designing and installing turnkey projects.

Job role: Quality Assurance & Regulatory Affairs Manager. Office based, Thame (hybrid). Permanent, Full-time, Monday–Friday, 40 hours per week. Benefits and salary details are provided below.


What you will be doing

* Own, manage, and continuously improve the company’s Quality Management System (QMS).
* Define, review, and ensure compliance with company quality procedures.
* Generate and review project and technical documentation.
* Compile and submit design and technical files.
* Liaise with Notified Bodies and regulatory authorities.
* Host Regulatory, Notified Body, and Customer audits, managing remediation plans where required.
* Manage contractors and suppliers in line with quality and regulatory standards.
* Support and perform device verification and validation activities.
* Ensure compliance with applicable national and international standards and regulations.
* Drive continuous improvement initiatives across the organisation.

This role includes line management of a Quality and Test Engineer.


Qualifications

Essential:

* Experience in a Regulatory / Quality leadership role.
* Quality management experience, ideally with Class IIb medical devices.
* Strong knowledge of QMS processes (CAPA, audits, supplier management, etc.).
* Experience with risk management (ISO 14971 desirable).
* Confident communicator, analytical thinker, and self-starter.
* Commercial awareness and ability to interpret regulatory requirements.

Desirable:

* Understanding of ISO 13485:2016.
* Experience writing, updating, and compiling Technical Files.
* Familiarity with global medical device regulations and standards.
* Knowledge of water purification processes (advantageous – training provided).


Additional Information

Why join us?

You will be part of a collaborative, forward-thinking team focused on delivering sustainable, technical solutions that support industry and protect the environment, with structured progression opportunities and flexibility to grow your career.

What we can offer you

We offer a comprehensive package designed to support your health, finances and life outside work. You’ll receive 26 days’ holiday plus bank holidays, with the flexibility to buy or sell additional leave, along with private healthcare and the option to add family members. A dental plan provides cover or cashback on treatments. All employees benefit from enhanced family-friendly policies and maternity/paternity leave provisions. Flexible working options such as remote work, adjusted hours, and paid/unpaid leave are available. Discounted gym memberships and one paid volunteering day per year are provided. Financially, the package includes: 10% employer pension contribution, option to buy company shares at preferential rates, salary sacrifice schemes, life insurance up to four times salary, income protection up to five years at 60% of salary, and potential lump sum if unable to return to work.

As an inclusive company, Veolia is committed to diversity and gives equal consideration to all applications, without discrimination.

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