Regulatory Affairs and Quality Lead
2 days ago
As a seasoned professional in regulatory affairs, you will oversee and manage functions that support departmental initiatives and directives in the European region. Your role will involve setting priorities, monitoring, and reporting on budget, planning, logistics, and acting as a regional coordinator for regulatory submissions and strategies.
This exciting and diverse position requires close collaboration with local organizations to ensure compliance with legislation and represent Elekta in International regulatory bodies. Key responsibilities include:
- Developing and maintaining Regional Submission Processes and Regulatory Roadmaps for the European region
- Providing interpretation and strategic advice to local organizations on changes in legislation
- Representing Elekta in interactions with international bodies in the field of regulatory submissions
- Supporting locally appointed regulatory and quality staff in their interactions with national authorities and in preparations of submissions and compliance data
The successful candidate will have more than 5+ years of experience working with regulatory affairs in the European region, with a stronger background in RA than QA. Knowledge of the European Directive for Medical Devices and experience of ISO 13485 are preferred. A degree equivalent in an engineering-related subject or a formal engineering apprenticeship is required.
In return for your expertise, you can expect a competitive salary of £60,000 - £80,000 per annum, depending on location, plus a range of benefits including up to 25 paid vacation days (plus bank holidays), a holiday purchase scheme, private medical insurance, an attractive employer pension contribution package, and hybrid work options.
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Director of Quality and Regulatory Affairs
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Crawley, West Sussex, United Kingdom Elekta AB Full timeJob OverviewWe are seeking a highly motivated and skilled Senior Quality Assurance and Regulatory Affairs Engineer to join our team. As a key member of our project teams, you will play a critical role in ensuring the quality and regulatory compliance of our products.
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Regulatory Affairs Director Europe
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Crawley, West Sussex, United Kingdom Manor Royal Business District Full timeJob DescriptionIn our prestigious Manor Royal Business District office, we are seeking a highly skilled Regulatory Affairs Director to oversee and manage functions supporting departmental initiatives and directives in the European region. This role involves setting priorities, monitoring budget, planning logistics, and acting as a regional coordinator for...
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Quality Assurance and Regulatory Expert
1 week ago
Crawley, West Sussex, United Kingdom Manor Royal Business District Full timeAbout the JobWe are seeking an experienced Regulatory Affairs professional with more than 5 years of experience working with regulatory affairs in the European region. Knowledge and proven track record in Regulatory Affairs for Medical Devices in the European region are essential. A degree equivalent in an engineering-related subject or a formal engineering...
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European Regulatory Lead
1 month ago
Crawley, West Sussex, United Kingdom Elekta AB Full timeKey ResponsibilitiesOversight of Regional Submission Processes and Regulatory Roadmaps for the European region.Provide strategic advice on changes in legislation and regulatory affairs for local organizations.Represent Elekta in international bodies and interactions with national authorities.
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Quality Lead European Region
1 month ago
Crawley, West Sussex, United Kingdom Manor Royal Business District Full timeAbout the RoleWe are looking for a Quality Lead to join our European Region team. As a key member of the team, you will be responsible for overseeing and managing functions that support departmental initiatives and directives in the European region. This role involves setting priorities, monitoring budget, planning logistics, and acting as a regional...
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Regulatory Compliance Expert in Healthcare
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Crawley, West Sussex, United Kingdom Elekta Full timeElekta is a leading medical technology company seeking a skilled Regulatory Compliance Expert to join our team in the UK or Sweden. In this role, you will be responsible for ensuring compliance to the quality management system and regulatory requirements and will play a key role in maintaining the high standards of quality and regulatory compliance that our...
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Regulatory Affairs Director
1 month ago
Crawley, West Sussex, United Kingdom Elekta AB Full timeAbout the RoleThis is an exciting opportunity to work closely with local organizations, ensuring compliance with legislation and representing Elekta in International regulatory bodies. You will be responsible for setting priorities, monitoring, and reporting on budget, planning, logistics, and acting as a regional coordinator for regulatory submissions and...
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Senior Quality Engineer for Medical Devices
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Regulatory Product Development Manager
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