Quality Assurance & Regulatory Affairs Manager

Quality Assurance & Regulatory Affairs Manager

Office based, Thame (hybrid)

Permanent, Full-time, Monday–Friday, 40 hours per week

Benefits: 26 days annual leave (plus UK bank holidays), pension scheme, private medical insurance and more!

Salary: Circa £55,000 depending on experience

We are seeking a proactive and experienced Regulatory Affairs & Quality Assurance (RAQA) Manager to support our established portfolio of non-medical laboratory water purification products and our historic range of water purification medical devices for the haemodialysis market.

This is a hands-on leadership role with direct responsibility for the execution, maintenance, and continuous improvement of the facility’s Quality Management System (QMS). You will take ownership of the QMS and ensure ongoing compliance with ISO9001, ISO14001, and ISO45001, supported by Group HSE and Quality teams as well as the local management team.

Experience with ISO13485, EU and UK Medical Device Regulations, and other relevant international standards is highly desirable, though not essential.

As part of a globally recognised organisation, this role offers a unique opportunity to contribute across multiple business functions, broaden your expertise, and grow within an international environment.
 

What you will be doing…
 

• Own, manage, and continuously improve the company’s Quality Management System

• 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.

 

What we are looking for…

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)
   

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 (currently with Bupa) and the option to add family members.

A dental plan provides cover or cashback on treatments, and all employees benefit from enhanced family-friendly policies — including 13 weeks’ full maternity / primary carer pay from day one (increasing with service), two weeks’ full paternity / co-parental pay, and adoption leave with 13 weeks’ full parental pay and two weeks’ co-parental pay from the start of employment.

We also support colleagues with caring responsibilities through flexible working options such as remote work, adjusted hours and paid or unpaid leave where needed.

To help you stay active and well, you’ll have access to discounted gym memberships.

In addition, every employee receives one paid volunteering day each year to give back to causes that matter to them.

From a financial perspective, we provide a market-leading benefits package including:

• A 10% employer pension contribution each month (doubling your own 5% contribution)
   

• The option to buy company shares at preferential rates
   

• Salary sacrifice schemes to support everyday savings
   

• Life insurance worth four times your salary, paid to your nominated beneficiaries
   

• Income protection for up to five years at up to 60% of your salary, plus a lump sum of twice your salary if you’re unable to return to work
   

Together, these benefits are designed to give you security, flexibility and support at every stage of your career and personal life.

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