apartmentTurning PointplaceLondon Borough of Hackney
As a Quality & GovernanceManager you’ll have the chance to make a real difference to thelives of the people we support who are experiencing difficultiesfrom substance use, playing a key role in ensuring quality ofservice delivery, and ensuring internal and external standards ofcare are upheld across...
apartmentUberplaceBroxbourne
Driving with Uber offers a flexible earning opportunity.It’s a great alternative to full-time driver jobs, part-time driver jobs or other part-time gigs, temp jobs or seasonal employment.Or maybe you’re already using other rideshare apps and want to supplement your income by becoming a driver using ...
apartmentUberplaceTadworth
Driving with Uber offers a flexible earning opportunity.It’s a great alternative to full-time driver jobs, part-time driver jobs or other part-time gigs, temp jobs or seasonal employment.Or maybe you’re already using other rideshare apps and want to supplement your income by becoming a driver using ...
placeLondon
of autoimmune and inflammatory diseases, as well as preventing rejection in organ transplantation, based on modular engineered Tregs. THE ROLE - Quality Control Scientist I / II The QC Scientist is accountable for participating in the effective running...
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Tour Promoter - Bath

apartmentRATP Dev / TootbusplaceEngland
Bus Tours Street Promoter – Bath City - Seasonal.We are seeking talented, enthusiastic, and dynamic customer-orientated BUS TOURS STREET PROMOTERS to join our On-Street Team in Bath City centre.You will be pivotal in attracting customers to experience the city in one of our open top buses.This is a ...
apartmentL&T Technology ServicesplaceFarnborough (Hampshire), 31 mi from London
Factory, and Autonomous Transport. We are looking for someone who is: Quality Control Specialist (Medical Industry) Farnborough, UK Responsibilities:  •  5-7 years of experience in quality control in the medical industry  •  Inspect incoming materials...
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Quality Control Analyst

apartmentVerbatim PharmaplaceElstree, 12 mi from London
Specialist / Quality Control Technician / Quality Inspector / Compliance Analyst / Process Control Analyst / Regulatory Compliance Specialist / Quality Assurance Auditor / Quality Control Coordinator / Validation Specialist / Laboratory Analyst / QC / Quality...
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Quality Control Specialist (QC)

apartmentL&T Technology ServicesplaceFarnborough (Hampshire), 31 mi from London
Transport. Quality Control Specialist (Medical Industry)   5.  7 years of experience in quality control in the medical industry ~ Inspect incoming materials, components, and finished products according to established quality standards and specifications...
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Quality & Regulatory Specialist

London | Permanent | £35,000 - £40,000/year | www.cv-library.co.uk |
TEC Partners is pleased to have partnered with a pioneering medical device company who is set to pave the way for AI-based automated analysis software to overcome a global crisis affecting millions of lives.

Quality and Regulatory Specialist

As the Quality and Regulatory Specialist, you will play a pivotal role in my client's mission to deliver groundbreaking solutions in global diagnostics. Your key responsibilities will include document control and the ability to implement robust document control processes while working closely with the Head of Quality and Regulatory Affairs establish the QMS aligned with ISO 13485 requirements, driving continuous improvement and operation excellence.

The successful candidate will also compile technical files with comprehensive documentation to support regulatory submission and product certification while conducting risk management activities in accordance with ISO 14971, identifying potential hazards, assessing risks and implementing effective mitigation strategies.

Quality and Regulatory Specialist Key Responsibilities:

Manage and organize quality and regulatory documentation
Ensure timely and accurate filing per industry standards
Maintain compliance with regulatory requirements
Collaborate with teams for regulatory compliance training
Implement robust document control processes
Maintain compliance throughout the product lifecycle
Assist with the development of comprehensive technical files for CE marking
Collaborate with stakeholders to establish a QMS

Quality and Regulatory Specialist Requirements:

Bachelor's degree in a relevant field (e.g., Engineering, Life Sciences, Regulatory Affairs)
2 years' experience in quality and regulatory affairs within the medical device industry, preferably with exposure to software (IEC 62304) and Software as a Medical Device (SaMD)
Strong understanding of ISO 13485, ISO 14971, and other relevant regulatory standards
Excellent communication skills with the ability to collaborate effectively across multidisciplinary teams
Detail-oriented mindset with a commitment to maintaining the highest standards of quality and compliance
Experience with CE marking processes and regulatory submissions is highly desirable

This is an exciting opportunity to be part of a dynamic and innovative company dedicated to making a meaningful impact on the lives of millions affected by diabetes. If you are driven by excellence, passionate about regulatory compliance, and eager to contribute to the future of healthcare, the Head of Quality and Regulatory Affairs is driven to help you develop your career with a clear pathway set to develop up to a managerial level.

If you're interested, please apply with an up to date CV as this role will not be available for long