Milton Keynes, 17 mi from Luton
for operational efficiency
Delivering recruitment support to enhance capacity and capability aligned with strategic priorities
Offering specialist advice on immigration and employment vetting matters to ensure compliance with statutory and regulatory...
Medicareplus International LtdBrent, 27 mi from Luton
the Regulatory Affairs Specialist is responsible for the completion of regulatory submissions for product registrations and post-market surveillance (PMS) and vigilance in line with the business needs.
Prepare submissions / regulatory compliance documents...
Medicareplus International LtdBrent, 27 mi from Luton
the Regulatory Affairs Specialist is responsible for the completion of regulatory submissions for product registrations and post-market surveillance (PMS) and vigilance in line with the business needs.
Prepare submissions / regulatory compliance documents...
Medicareplus International LtdBrent, 27 mi from Luton
the Regulatory Affairs Specialist is responsible for the completion of regulatory submissions for product registrations and post-market surveillance (PMS) and vigilance in line with the business needs.
Prepare submissions / regulatory compliance documents...
MeetLondon, 30 mi from Luton
Regulatory Affairs Custom Device Team Lead / Senior Regulatory Affairs Custom Device Associate Main Purpose of Job and Objectives: Perform Regulatory tasks to ensure compliance with regulations.
Prepare regulatory documentation and submissions...
Verbatim PharmaSt Albans, 11 mi from Luton
culture
• Hertfordshire based
Verbatim Pharma are looking for a GMP Compliance Specialist to play a pivotal role in delivering sound guidance to the Manufacturing department.
Not only will you draw on your attention to detail, but passion for getting...
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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
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
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