Average salary: £110,170 /yearly
More statsSearch Results: 115 vacancies
£26k - £35k per annumEstimated
...Responsibilities (but not limited to):
• Creation and maintenance of Clinical Evaluation according to MEDDEV 2.7.1, Rev. 4 and compliant to EU/UK MDR (Medical Device Regulation)
• Ensure that clinical evaluation plans/reports and databases are kept compliant and up to date.
•...
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Permanent employment
Full time
Contract work
Work at office
No agency
Flexible hours
...regulatory submissions for medical devices. With a market-leading reputation, our client specialises in preparing top-tier submissions under EU MDR, IVDR, FDA, and beyond.
As part of our esteemed team, you'll have the opportunity to grow and thrive in a stimulating career...
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Work at office
Flexible hours
...Packaging, deployment and configuration of applications
Management and administration of endpoint protection technologies such as XDR/MDR tools
Management and administration of cloud and on-premise backup technologies
Administration of multi-factor authentication...
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Remote job
Employment trial period
Hybrid work
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Shift work
Rotating shift
Saturday
Working Monday to Friday
...online help systems
Strong knowledge of human factors/usability standards, guidelines and regulations (such as ISO 62366, 62304, FDA and MDR)
Excellent communication and report writing skills
Knowledge of statistical analysis software packages (such as SAS, R, Matlab) is...
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Full time
Remote job
Hybrid work
...experience in Medical devices (class I and IIa).
Experience in Technical files and Post market surveillance.
Expert knowledge of MDR, ISO13485, UK MDR.
Experience interacting with Notified/Approved Body.
Please share your CV at (url removed) if you are interested...
Suggested
Permanent employment
...Device manufacturer.
Our client, a leading medical device company, is seeking a Regulatory Specialist with expertise in FDA regulations, MDR, and technical files. In this role, you will play a pivotal role in ensuring regulatory compliance and driving the success of their...
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Remote job
...variety of sectors including Finance, IT, Public Sector and Healthcare. The organisation provide Sentinel SIEM powered SOC capabilities (XDR/MDR) to customers globally to ensure threats to their infrastructure cause minimal disruption and are remediated quickly.
They are...
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Hybrid work
...quality assurance experience ideally including the medical industry
Experience with ISO 13485 Medical Standard and knowledge of EU MDR 2017/745 & local regulations
Strong planning and organization skills
Ability to work remotely and effectively with remote teams,...
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Local area
Remote job
...environment.
Experience in the medical devices industry is preferred, with knowledge of relevant regulations such as ISO Standards, FDA, MDD, MDR, and MDSAP.
Our client is committed to supporting the well-being and professional growth of their employees. In addition to a...
Suggested
Holiday work
£55k - £60k per annum
...skills - managing and overseeing the professional development of team members.
ISO 9001 / ISO 13485
FDA / 93/42/EEC MDD & 2017/745 MDR
Proven experience of managing a team
Ability to liaise across teams globally, manage communication difficulties, compliance as...
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Permanent employment
Temporary work
Worldwide
Overseas
...above.
Exceptional written English with a keen eye for detail.
Familiarity with international regulatory affairs including EU MDD/MDR, FDA, and other pertinent regulations.
Capability to swiftly grasp new concepts and evaluate scientific data.
Proficiency in IT...
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Work at office
Flexible hours
...Key responsibilities:
Create, put into action, and keep up the Quality Management System (QMS) following ISO 9001, ISO 13485, UK MDR 2002, and (EU) MDR 2017/745.
Lead internal checks, help with external checks, and make sure issues found during checks are quickly fixed...
Suggested
...communicating to Operations stakeholders
Oversight, monitoring and regulatory reporting (where necessary) of Mandatory Disclosure Rules (MDR) and UK BBSI reporting
The ideal candidate will be able to demonstrate significant experience in operational taxes, from an...
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Relief
....
You will be responsible for maintaining and updating technical documentation, ensuring compliance with regulations such as MDD to MDR (Medical Device Regulation).
- Safety Data Sheets (SDS): As our client currently outsources this task, we are looking for someone who...
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Remote job
...documented in accordance with Medical Device Single Audit Program (MDSAP), Medical Device Directive (MDD) and Medical Device Regulation (MDR);
Support the promotion of quality awareness of applicable quality requirements and Business Management System requirements...
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...stakeholders (CS, GPSS, GDCM, Quality, IT, outsourced partners) to define potential for process improvement and/or changes. Ensure compliance to MDR and GDPR. Provide gap analysis and remediation plans where needed for execution by the CS teams. Drive Product Complaint process...
Remote job
...effective countermeasures in line with procedures, ISO 13485, Medical Device Single Audit Program (MDSAP) and Medical Device Regulation (MDR);
Undertake a proactive approach with both internal stakeholders and suppliers to reduce the overall cost of poor quality....
.... Experience with implementing and maintaining Quality Management Systems (QMS) in accordance with ISO standards.
· Knowledge of global regulatory requirements applicable to the company's products and services, such as (EU) 2017/745, UK MDR 2002, FDA regulations, etc.
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...development of various technical documents, clinical investigation files, and the preparation of regulatory submissions compliant with EU MDR, IVDR, and FDA requirements.This is a beautifully varied role where you'll collaborate on multiple projects and engage in conferences...
Work at office
Work from home
Home office
3 days week
£35k - £50k per annum
...design team)
Experience of developing medical devices (an understanding of FDA human factors guidelines, IEC62366 and the latest MDR requirements)
Experience of working in highly regulated environments (e.g. medical, rail, nuclear, etc.)
Interested or know someone...
