Quality Assurance & Regulatory Affairs Manager
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Job Location:
Oxfordshire - UK
Monthly Salary:
Not Disclosed
Posted on:
11 hours ago
Vacancies:
1 Vacancy
Job Summary
Quality Assurance & Regulatory Affairs Manager
Office based Thame (hybrid)
Permanent Full-time MondayFriday 40 hours per week
Benefits: 26 days annual leave (plus UK bank holidays) pension scheme private medical insurance and more!
Salary: Circa 55000 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 facilitys 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 companys 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.
Qualifications :
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)
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. Youll 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 youll 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 youre 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.
Remote Work :
No
Employment Type :
Full-time
Key Skills
About Company
Veolia aims to be the benchmark company for ecological transformation. Our mission to Resource the world demonstrates the unwavering commitment of our 220,000 employees to creating a positive impact for our planet. By joining Veolia Water Technologies, not only will you become a Re ... View more
